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| ID | Type | Description | Link |
|---|---|---|---|
| ZIAAR041138-08 | U.S. NIH Grant/Contract | View source | |
| NCT00069329 | Other Identifier | National Institutes of Health | |
| 03-AR-0298 | Other Identifier | NIHCC |
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data submitted for Food and Drug Administration (FDA) approval
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This study will evaluate the safety and effectiveness of anakinra (Kineret) for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, eye problems, and learning difficulties. Immune suppressing medicines commonly used to treat other pediatric rheumatologic diseases do not suppress NOMID symptoms and, if used long-term and in high doses, can cause harmful side effects. Anakinra, approved by The Food and Drug Administration for treating rheumatoid arthritis in adults, blocks a substance called IL-1 that may be an important factor in causing the inflammation in NOMID.
This study uses the IL-1 receptor antagonist anakinra to treat children and adults with Neonatal-Onset Multisystem Inflammatory Disease (NOMID), also known as chronic infantile neurological, cutaneous and arthropathy (CINCA) syndrome. NOMID/CINCA syndrome is a rare genetic systemic auto-inflammatory disease that is characterized by a triad of symptoms, including a persistent urticaria-like skin rash, an arthropathy associated with patellar and epiphyseal osseous overgrowth, and neurological manifestations, including chronic aseptic meningitis, optic disc edema, high frequency hearing loss, and mental retardation. Spontaneous genetic mutations in the NACHT domain of CIAS1, a gene located on chromosome 1 have been recently identified in about half of the patients with NOMID/CINCA syndrome. CIAS1 encodes a protein, cryopyrin that is associated with up-regulation of IL-1 production in vitro, which has formed the rationale to target the IL-1 pathway in children with NOMID. During an up to 3- week enrollment period before initiating therapy, we will collect self/parent reported daily diary data and serological samples on up to 3 occasions one week apart, to determine baseline disease activity. These data may be gathered by collaborating centers. At the end of the observation period, patients will be admitted to the NIH for a standardized clinical evaluation and initiation of treatment with anakinra administered at 1 mg/kg/day by regular daily subcutaneous injections. If patients do not fulfill improvement criteria at 1 month, the dose will be escalated between 0.5 and 1 mg/kg/day increments to obtain inflammatory remission. An initial withdrawal study in a subset of 11 patients was performed. The clinical improvement at 3-4 months and the change in serum amyloid A levels (SAA) (a sensitive inflammatory marker) from before treatment to 3-4 months post treatment, and drug safety are the primary clinical outcomes of this study. To assess long-term safety and efficacy, all patients will be observed during an open ended extension phase of the study. Clinical and laboratory parameters will be used to assess safety and efficacy throughout the trial. All patients will be seen every 6 months and annually (as calculated from initiation of anakinra treatment) to further evaluate safety and long term outcomes. During the open ended extension phase of the study, patients who have residual clinical or laboratory evidence of active inflammation may have their dose increased between 0.5 and 1 mg/kg/day increments to a maximum dose of 10 mg/kg/per day to achieve clinical remission. In addition, since no data on the pharmacokinetics (PK) of anakinra in pediatric patients is available with doses exceeding 2 mg/kg/day, we plan to determine the PK of anakinra with each dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOMID treatment arm | Experimental | All patients enrolled received daily doses of subcutaneous injection of increased doses of anakinra starting at 0.5mg/kg/day up to a maximum 10mg/kg/day to achieve disease remission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anakinra | Drug | daily injection of subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | Baseline |
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | 36 months |
| Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | 60 months |
| Patient / Parent Global Score of Overall Disease Activity |
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-INCLUSION CRITERIA:
There is no age limitation.
Patients fulfill at least 2 of the following 3 clinical manifestations:
Onset of manifestations of NOMID/CINCA at less than or equal to 6 months of age.
Stable dose of steroids, NSAIDs, DMARDs for 4 weeks prior to enrollment visit.
Washout period for biologics: 6 half-lives before anakinra administration for all drugs with anti TNF properties. For etanercept (6 half-lives=24 days) this calculates to drug discontinuation 3 days before enrollment into the observation period, for infliximab and adalimumab (6 half-lives=48 days) drug will be discontinued 27 before the observation period, and for thalidomide (6 half-lives=3 days) drug will be discontinued for 3 days prior to anakinra administration.
Patient's or legal guardian's ability and willingness to give informed consent.
Females of childbearing potential (young women who have had at least one menstrual period regardless of age) must have a negative urine pregnancy test at baseline prior to performance of any radiologic procedure or administration of study medication. Women of childbearing age and men able to father a child, who are sexually active, will be asked to use a form of effective birth control, including abstinence.
Negative PPD test using 5 T.U. intradermal testing per CDC guidelines with exception of inclusion criteria #9 below.
Patients with latent TB (positive PPD test) must have adequate therapy for TB initiated prior to first dose of study medication as recommended in published guidelines.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Raphaela T Goldbach-Mansky, M.D. | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12032915 | Background | Feldmann J, Prieur AM, Quartier P, Berquin P, Certain S, Cortis E, Teillac-Hamel D, Fischer A, de Saint Basile G. Chronic infantile neurological cutaneous and articular syndrome is caused by mutations in CIAS1, a gene highly expressed in polymorphonuclear cells and chondrocytes. Am J Hum Genet. 2002 Jul;71(1):198-203. doi: 10.1086/341357. Epub 2002 May 24. | |
| 9108844 | Background | Hashkes PJ, Lovell DJ. Recognition of infantile-onset multisystem inflammatory disease as a unique entity. J Pediatr. 1997 Apr;130(4):513-5. No abstract available. |
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with Swedish Orphan Biovitrum Inc (SOBI)
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| ID | Title | Description |
|---|---|---|
| FG000 | NOMID | Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NOMID | Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission. |
| 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 | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
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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 | NOMID | Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospital admission for cardiac catheterization | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angiodema Right ring finger | Cardiac disorders | Systematic Assessment |
Data reported is on 26 patients who completed their 3 year assessment and 20 of these patients also completed their 5 year assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Goldbach-Mansky, Raphaela | National Inst of Arthritis and Musculoskeletal and Skin Diseases | +1 301 435 6243 | goldbacr@mail.nih.gov |
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| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D001177 | Arthropathy, Neurogenic |
| D014581 | Urticaria |
| D010211 | Papilledema |
| D000013 | Congenital Abnormalities |
| D007592 | Joint Diseases |
| D056587 | Cryopyrin-Associated Periodic Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm).
| Baseline |
| Patient / Parent Global Score of Overall Disease Activity | Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm). | 36 months |
| Patient / Parent Global Score of Overall Disease Activity | Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm). | 60 months |
| Parent /Patient Pain Rating | Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | Baseline |
| Parent /Patient Pain Rating | Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | 36 months |
| Parent /Patient Pain Rating | Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | 60 months |
| Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | Baseline |
| Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | 36 months |
| Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | 60 months |
| Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | Baseline |
| Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | 36 months |
| Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | 60 months |
| C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | Baseline |
| C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | 36 months |
| C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | 60 months |
| Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | Baseline |
| Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | 36 months |
| Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | 60 months |
| 11687797 | Background | Hoffman HM, Mueller JL, Broide DH, Wanderer AA, Kolodner RD. Mutation of a new gene encoding a putative pyrin-like protein causes familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Nat Genet. 2001 Nov;29(3):301-5. doi: 10.1038/ng756. |
| 28118536 | Derived | Rodriguez-Smith J, Lin YC, Tsai WL, Kim H, Montealegre-Sanchez G, Chapelle D, Huang Y, Sibley CH, Gadina M, Wesley R, Bielekova B, Goldbach-Mansky R. Cerebrospinal Fluid Cytokines Correlate With Aseptic Meningitis and Blood-Brain Barrier Function in Neonatal-Onset Multisystem Inflammatory Disease: Central Nervous System Biomarkers in Neonatal-Onset Multisystem Inflammatory Disease Correlate With Central Nervous System Inflammation. Arthritis Rheumatol. 2017 Jun;69(6):1325-1336. doi: 10.1002/art.40055. Epub 2017 May 10. |
| 27143789 | Derived | Kullenberg T, Lofqvist M, Leinonen M, Goldbach-Mansky R, Olivecrona H. Long-term safety profile of anakinra in patients with severe cryopyrin-associated periodic syndromes. Rheumatology (Oxford). 2016 Aug;55(8):1499-506. doi: 10.1093/rheumatology/kew208. Epub 2016 May 3. |
| 25223501 | Derived | Chang Z, Spong CY, Jesus AA, Davis MA, Plass N, Stone DL, Chapelle D, Hoffmann P, Kastner DL, Barron K, Goldbach-Mansky RT, Stratton P. Anakinra use during pregnancy in patients with cryopyrin-associated periodic syndromes (CAPS). Arthritis Rheumatol. 2014 Nov;66(11):3227-32. doi: 10.1002/art.38811. |
| 22294344 | Derived | Sibley CH, Plass N, Snow J, Wiggs EA, Brewer CC, King KA, Zalewski C, Kim HJ, Bishop R, Hill S, Paul SM, Kicker P, Phillips Z, Dolan JG, Widemann B, Jayaprakash N, Pucino F, Stone DL, Chapelle D, Snyder C, Butman JA, Wesley R, Goldbach-Mansky R. Sustained response and prevention of damage progression in patients with neonatal-onset multisystem inflammatory disease treated with anakinra: a cohort study to determine three- and five-year outcomes. Arthritis Rheum. 2012 Jul;64(7):2375-86. doi: 10.1002/art.34409. |
| 16899778 | Derived | Goldbach-Mansky R, Dailey NJ, Canna SW, Gelabert A, Jones J, Rubin BI, Kim HJ, Brewer C, Zalewski C, Wiggs E, Hill S, Turner ML, Karp BI, Aksentijevich I, Pucino F, Penzak SR, Haverkamp MH, Stein L, Adams BS, Moore TL, Fuhlbrigge RC, Shaham B, Jarvis JN, O'Neil K, Vehe RK, Beitz LO, Gardner G, Hannan WP, Warren RW, Horn W, Cole JL, Paul SM, Hawkins PN, Pham TH, Snyder C, Wesley RA, Hoffmann SC, Holland SM, Butman JA, Kastner DL. Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition. N Engl J Med. 2006 Aug 10;355(6):581-92. doi: 10.1056/NEJMoa055137. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| NOMID |
Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission. |
|
|
| Primary | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 36 months |
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| Primary | Diary Symptom Sum Score (DSSS) (Fever, Rash, Joint Pain, Vomiting, and Headaches) | "The severity of the main symptoms of the disease were scored on a scale from 0 (no symptoms) to 4 (highest severity) on a daily basis using a diary. Five key symptoms were included in the primary variable DSSS: fever, headache, rash, joint pain, and vomiting. Each of the diary variables was evaluated as a mean value for a period preceding the visits. The baseline value was the mean value of the 5-30 last days before the first dose of Kineret. For the subsequent visits, the mean value of the last 30 days with data before each visit was used as the response variable." | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Primary | Patient / Parent Global Score of Overall Disease Activity | Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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|
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| Primary | Patient / Parent Global Score of Overall Disease Activity | Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 36 months |
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| Primary | Patient / Parent Global Score of Overall Disease Activity | Visual analog assessment of how arthritis affects the patient as rated by the patient themselves or parent. Measured on scale from very well (0 mm) to very poor (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Primary | Parent /Patient Pain Rating | Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Parent /Patient Pain Rating | Visual analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 36 months |
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| Primary | Parent /Patient Pain Rating | Visual Analog assessment of how much pain the patient experienced in past week due to illness as rated by the patient themselves or parent. Measured on scale from no pain (0 mm) to very severe pain (100 mm). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Primary | Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| Primary | Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities.Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 36 months |
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| Primary | Childhood Health Assessment Questionnaire (CHAQ) | Patient self-assessment (or parent assessment) for how illness affects ability to function in daily life. Includes overall score, overall pain rating, overall global evaluation, subcategories for dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities. Measured on scale of 0-3 from 'Without any difficulty' (0) to 'Unable to do' (3). | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | units on a scale | 60 months |
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| Primary | Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mg/liter | Baseline |
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| Primary | Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mg/liter | 36 months |
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| Primary | Serum Amyloid A (SAA) Measurement | Serum Amyloid A is an inflammatory marker for NOMID measured using Rapid Automated Enzyme Immunoassay. Normal SAA values were defined as ≤ 10 mg/liter. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | mg/liter | 60 months |
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| Primary | C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mg/dl | Baseline |
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|
|
| Primary | C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mg/dl | 36 months |
|
|
|
| Primary | C-reactive Protein (CRP) Measurement | C-reactive protein (CRP) is an inflammatory marker for NOMID. Systemic inflammatory remission was defined as a normal CRP level (≤0.5mg/dl). Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | mg/dl | 60 months |
|
|
|
| Primary | Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg/day per injection were made as frequently as every 2 weeks to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mm/hour | Baseline |
|
|
|
| Primary | Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 4.5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 26 patients who completed their 3 year assessment. | Posted | Mean | Standard Deviation | mm/hour | 36 months |
|
|
|
| Primary | Erythrocyte Sedimentation Rate (ESR) Measurement | Erythrocyte Sedimentation Rate (ESR) is an inflammatory marker for NOMID. Normal ESR values are defined as ≤ 25 mm/hour. Analyzed at the NIH Clinical Center Laboratory. | Patients started at 1mg/kg by daily subcutaneous injection. Stepwise dose increases of 0.5-1 mg/kg per injection were made as frequently as every 2 weeks up to 5 mg/kg/day to achieve laboratory and organ inflammation remission. Data reported is on 20 patients who completed their 5 year assessment. | Posted | Mean | Standard Deviation | mm/hour | 60 months |
|
|
|
| 18 |
| 43 |
| 43 |
| 43 |
| Uveitis | Eye disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | Systematic Assessment |
|
| Acute Tonsillitis/tooth abscess | Infections and infestations | Systematic Assessment |
|
| Appendicitis | Infections and infestations | Systematic Assessment |
|
| Arthritis | Infections and infestations | Systematic Assessment |
|
| Cellulitis Right lower extremity | Infections and infestations | Systematic Assessment |
|
| Left cervical lymphadenitis | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Meningitis | Infections and infestations | Systematic Assessment |
|
| Pneumonitis | Infections and infestations | Systematic Assessment |
|
| Right ankle cellulitis | Infections and infestations | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Metabolic toxicity | Metabolism and nutrition disorders | Systematic Assessment |
|
| generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Meningitis | Nervous system disorders | Systematic Assessment |
|
| Pain | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | Systematic Assessment |
|
| Double Mastectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Low grade focal ductal carcinoma in-situ of left breast | Reproductive system and breast disorders | Systematic Assessment |
|
| Right breast inflammation post surgery | Reproductive system and breast disorders | Systematic Assessment |
|
| Right breast scar/fibrotic tissue excised from inplant capsule | Reproductive system and breast disorders | Systematic Assessment |
|
| Hospitalized for Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bilateral Capsulectomy with permenant implants | Surgical and medical procedures | Systematic Assessment |
|
| L ureter stent placed | Surgical and medical procedures | Systematic Assessment |
|
| Left renal stent removal | Surgical and medical procedures | Systematic Assessment |
|
| Lithotripsy | Surgical and medical procedures | Systematic Assessment |
|
| Post-Surgery Pneumonia | Surgical and medical procedures | Systematic Assessment |
|
| Suicidal ideation | Surgical and medical procedures | Systematic Assessment |
|
| Chest wall pain | Cardiac disorders | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | Systematic Assessment |
|
| Vasovagal reaction | Cardiac disorders | Systematic Assessment |
|
| ear drainage | Ear and labyrinth disorders | Systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| weight gain | Endocrine disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Dry eye | Eye disorders | Systematic Assessment |
|
| Eye infection | Eye disorders | Systematic Assessment |
|
| eye inflammation (left) | Eye disorders | Systematic Assessment |
|
| Eye pain | Eye disorders | Systematic Assessment |
|
| eye throbbing | Eye disorders | Systematic Assessment |
|
| foreign body in eye | Eye disorders | Systematic Assessment |
|
| Glaucoma | Eye disorders | Systematic Assessment |
|
| hemmorage in eye | Eye disorders | Systematic Assessment |
|
| itchy eyes | Eye disorders | Systematic Assessment |
|
| Nystagmus | Eye disorders | Systematic Assessment |
|
| Pain in extremity | Eye disorders | Systematic Assessment |
|
| sty on left eye | Eye disorders | Systematic Assessment |
|
| vision - eye twitch | Eye disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Alanine aminotransferase increased | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | Systematic Assessment |
|
| Aspartate aminotransferase increased | Gastrointestinal disorders | Systematic Assessment |
|
| canker sore | Gastrointestinal disorders | Systematic Assessment |
|
| Cold Sore on Gums | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Liver Enzymes | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Uveitis | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Weight loss | Gastrointestinal disorders | Systematic Assessment |
|
| Disease Flare | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Flare Symptoms (pt had 1 week of no anakinra) | General disorders | Systematic Assessment |
|
| Flare, ran out of anakinra | General disorders | Systematic Assessment |
|
| Insomnia | General disorders | Systematic Assessment |
|
| Irritability | General disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| NOMID Flare | General disorders | Systematic Assessment |
|
| bicarbonate | Blood and lymphatic system disorders | Systematic Assessment |
|
| blood / Bone Marrow - Other - elevated Hematocrit | Blood and lymphatic system disorders | Systematic Assessment |
|
| blood / Bone Marrow - Other - eosinophilia | Blood and lymphatic system disorders | Systematic Assessment |
|
| blood / Bone Marrow - Other - low reticulocyte count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Blood bilirubin increased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Bruising | Blood and lymphatic system disorders | Systematic Assessment |
|
| Epistaxis | Blood and lymphatic system disorders | Systematic Assessment |
|
| hemoglobin | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hypomagnesemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Hyponatremia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Proteinuria | Blood and lymphatic system disorders | Systematic Assessment |
|
| Transient elevation of LFT's | Blood and lymphatic system disorders | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | Systematic Assessment |
|
| Allergic rhinitis | Immune system disorders | Systematic Assessment |
|
| Allergic rhinitis | Infections and infestations | Systematic Assessment |
|
| Blastocystis Hominis Infection | Infections and infestations | Systematic Assessment |
|
| bowel abcess | Infections and infestations | Systematic Assessment |
|
| Bronchial infection | Infections and infestations | Systematic Assessment |
|
| Candida on palms and soles of feet bilaterally | Infections and infestations | Systematic Assessment |
|
| C-Diff Recurrence | Infections and infestations | Systematic Assessment |
|
| Chest Infection (?Pneumonia) | Infections and infestations | Systematic Assessment |
|
| Chest wall pain | Infections and infestations | Systematic Assessment |
|
| Chills | Infections and infestations | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | Systematic Assessment |
|
| Croup | Infections and infestations | Systematic Assessment |
|
| ear drainage | Infections and infestations | Systematic Assessment |
|
| Ear pain | Infections and infestations | Systematic Assessment |
|
| Eczema / Atopic Dermatitis | Infections and infestations | Systematic Assessment |
|
| External ear inflammation | Infections and infestations | Systematic Assessment |
|
| Fever | Infections and infestations | Systematic Assessment |
|
| Flu like symptoms | Infections and infestations | Systematic Assessment |
|
| Folliculitis - L-Groin | Infections and infestations | Systematic Assessment |
|
| G Tube Infection | Infections and infestations | Systematic Assessment |
|
| Gastritis | Infections and infestations | Systematic Assessment |
|
| Gastrointestinal pain | Infections and infestations | Systematic Assessment |
|
| Hand-Foot-Mouth Disease | Infections and infestations | Systematic Assessment |
|
| Headache | Infections and infestations | Systematic Assessment |
|
| Hearing impaired | Infections and infestations | Systematic Assessment |
|
| Hypopyon - Left eye | Infections and infestations | Systematic Assessment |
|
| infected finger | Infections and infestations | Systematic Assessment |
|
| infection without Neutropenia | Infections and infestations | Systematic Assessment |
|
| infection without Neutropenia - (yeast) | Infections and infestations | Systematic Assessment |
|
| infection without Neutropenia - Left arm thrombophlebitis | Infections and infestations | Systematic Assessment |
|
| infection without Neutropenia - tonsillitis with sore throat | Infections and infestations | Systematic Assessment |
|
| infection without Neutropenia (tooth abcess) | Infections and infestations | Systematic Assessment |
|
| itchy | Infections and infestations | Systematic Assessment |
|
| Lice | Infections and infestations | Systematic Assessment |
|
| Lung infection | Infections and infestations | Systematic Assessment |
|
| Mouth Infection | Infections and infestations | Systematic Assessment |
|
| mouth sores | Infections and infestations | Systematic Assessment |
|
| Nasal congestion | Infections and infestations | Systematic Assessment |
|
| Oral Ulcer | Infections and infestations | Systematic Assessment |
|
| Otitis externa | Infections and infestations | Systematic Assessment |
|
| Otitis media | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Pneumonitis | Infections and infestations | Systematic Assessment |
|
| R ear D/C | Infections and infestations | Systematic Assessment |
|
| Red & burning sensation on bottom of feet | Infections and infestations | Systematic Assessment |
|
| ringworm | Infections and infestations | Systematic Assessment |
|
| Rotaviral Infection | Infections and infestations | Systematic Assessment |
|
| RSV (Resp. Syncytial Virus) | Infections and infestations | Systematic Assessment |
|
| RSV infection | Infections and infestations | Systematic Assessment |
|
| Scalp Lesion (? Tinea capitis) | Infections and infestations | Systematic Assessment |
|
| scarlett fever | Infections and infestations | Systematic Assessment |
|
| Shingles | Infections and infestations | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Skin infection | Infections and infestations | Systematic Assessment |
|
| sore throat | Infections and infestations | Systematic Assessment |
|
| Strep throat | Infections and infestations | Systematic Assessment |
|
| strep throat (2x) | Infections and infestations | Systematic Assessment |
|
| Stye | Infections and infestations | Systematic Assessment |
|
| Throat infection | Infections and infestations | Systematic Assessment |
|
| Tooth infection (?abscess) | Infections and infestations | Systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urinary tract pain | Infections and infestations | Systematic Assessment |
|
| Viral Illness | Infections and infestations | Systematic Assessment |
|
| Viral Illness Dehydration | Infections and infestations | Systematic Assessment |
|
| Viral Infection | Infections and infestations | Systematic Assessment |
|
| Viral Infection Fever, Lethargy | Infections and infestations | Systematic Assessment |
|
| Vision loss | Infections and infestations | Systematic Assessment |
|
| yeast infection | Infections and infestations | Systematic Assessment |
|
| Auto Accident | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Physical Assault | Injury, poisoning and procedural complications | Systematic Assessment |
|
| CPK increased | Investigations | Systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Anxiety | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Conjunctivitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dysmenorrhea | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Edema limbs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fatigue | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Flu like symptoms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Gait disturbance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Malaise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osgood-Schlatter | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| restless leg syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| S/P L Knee growth plate fixation/fever thematoma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| A.D.D. | Nervous system disorders | Systematic Assessment |
|
| Allergic reaction | Nervous system disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Systematic Assessment |
|
| Blurred vision | Nervous system disorders | Systematic Assessment |
|
| carpal tunnel - right | Nervous system disorders | Systematic Assessment |
|
| cerebrospinal fluid leakage | Nervous system disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| External ear pain | Nervous system disorders | Systematic Assessment |
|
| Fever | Nervous system disorders | Systematic Assessment |
|
| Generalized muscle weakness | Nervous system disorders | Systematic Assessment |
|
| Glaucoma | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hearing impaired | Nervous system disorders | Systematic Assessment |
|
| Hoarseness | Nervous system disorders | Systematic Assessment |
|
| Nausea | Nervous system disorders | Systematic Assessment |
|
| Neck pain | Nervous system disorders | Systematic Assessment |
|
| Pain in extremity | Nervous system disorders | Systematic Assessment |
|
| Paresthesia of R hand suggestive of carpel tunnel | Nervous system disorders | Systematic Assessment |
|
| Saccadic Pursuit Neuropathy - Cranial | Nervous system disorders | Systematic Assessment |
|
| Seizure | Nervous system disorders | Systematic Assessment |
|
| Uveitis | Nervous system disorders | Systematic Assessment |
|
| Vertigo | Nervous system disorders | Systematic Assessment |
|
| vomiting | Nervous system disorders | Systematic Assessment |
|
| Bladder infection | Renal and urinary disorders | Systematic Assessment |
|
| Catheter related infection | Renal and urinary disorders | Systematic Assessment |
|
| Flank pain | Renal and urinary disorders | Systematic Assessment |
|
| glucosuria | Renal and urinary disorders | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
| Ketonuria | Renal and urinary disorders | Systematic Assessment |
|
| metabolic (elevated BUN) | Renal and urinary disorders | Systematic Assessment |
|
| metabolic / Laboratory - Other - elevated Blood Urea Nitrogen | Renal and urinary disorders | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
|
| Renal calculi | Renal and urinary disorders | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Upper respiratory infection | Renal and urinary disorders | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | Systematic Assessment |
|
| Breakthrough bleeding (menstrual) | Reproductive system and breast disorders | Systematic Assessment |
|
| Phantom pain of breats bilateraly | Reproductive system and breast disorders | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gait disturbance | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stridor | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Allergic reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| bug bite | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cyst on Right cheek | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Eczema (contact dermatitis) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| eczematous reaction to injection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Erythema Left Foot | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| eye swollen | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| fungal rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hive | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| hives | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hot/diaphoretic in summer months - rash at beltline | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Ingrown toenail | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Intermittent rash on body | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| lesion on scrotum | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Oral Ulcers | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Papulopustular rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Penile pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Perineal pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| R. 2nd toenail injury with ingrown nail | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash - (contact dermatitis) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash - adhesive (IV site) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash - Bugbite - R ear | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash - Lichenified rash on glutial crack | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash - Reaction to U-bag | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash (viral infection) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| rash / desquamation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash arms, trunk, legs | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash on Arms | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash on Right Leg | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| rashes | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| red cheeks | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Red Dots | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| red dots - rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Red Dots on Arm | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Cesarean Section | Surgical and medical procedures | Systematic Assessment |
|
| Dental Surgery Outpatient | Surgical and medical procedures | Systematic Assessment |
|
| Elective L cochlear implant surgery | Surgical and medical procedures | Systematic Assessment |
|
| Elective Osteotomy | Surgical and medical procedures | Systematic Assessment |
|
| Endoscopy to replace G Tube | Surgical and medical procedures | Systematic Assessment |
|
| eye surgery | Surgical and medical procedures | Systematic Assessment |
|
| hand surgery - carpal tunnel | Surgical and medical procedures | Systematic Assessment |
|
| Kidney Stent removal | Surgical and medical procedures | Systematic Assessment |
|
| Lithotripsy/stent removed | Surgical and medical procedures | Systematic Assessment |
|
| Placement of BMT (tubes) | Surgical and medical procedures | Systematic Assessment |
|
| staples in knee (surgery) | Surgical and medical procedures | Systematic Assessment |
|
| Surgery Adenoidectomy, Placement of bilateral myringotomy tubes | Surgical and medical procedures | Systematic Assessment |
|
| surgery for cyst removal | Surgical and medical procedures | Systematic Assessment |
|
| surgery on right knee | Surgical and medical procedures | Systematic Assessment |
|
| surgery on wrist | Surgical and medical procedures | Systematic Assessment |
|
| Tonsillectomy | Surgical and medical procedures | Systematic Assessment |
|
| Ureteral stent for renal calculi - Right kidney | Surgical and medical procedures | Systematic Assessment |
|
| Wisdom Teeth Extraction | Surgical and medical procedures | Systematic Assessment |
|
| hypertension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D012873 | Skin Diseases, Genetic |
| D000094482 | Chronic Inducible Urticaria |
| D000080223 | Chronic Urticaria |
| D000096703 | Cold Urticaria |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 | Proteins |
| D001685 | Biological Factors |