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Few interventions to improve asthma management have targeted low-income minority asthmatic adults and even fewer have focused on the real-world practice where care is provided for these patients. This project tests the effectiveness of a Patient Advocate as a practical and sustainable method of facilitating and maintaining communication between patient and provider and access to chronic care for adults with moderate or severe asthma recruited from clinics serving low-income urban neighborhoods. We compare the use of a Patient Advocate to current asthma care and test the Patient Advocate's cost-effectiveness.
This 5 year project tests the effectiveness, sustainability, and budget impact of a patient navigator intervention to facilitate and maintain patient-provider communication and access to chronic care of moderate or severe asthma in low income minority adults with other chronic morbidities. We will recruit from a variety of clinic practices including those of an urban academic health center, a VA, and a federally qualified health center and in both English-speaking and Spanish-speaking patients. The intervention is tailored to patients and their clinics, and informed by focus groups of patients and providers.
The Patient Advocate (PA), works with patients by coaching and modeling preparation for a visit with the asthma doctor, attending the visit with the permission of participant and provider, and confirming understanding of issues discussed. The PA also facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and exchange of information between providers and patients. The PAs are recent college graduates interested in health-related or education careers, research experience, working with patients, and generally have the same race/ethnicity distribution as potential subjects.
This dissemination and implementation project refines the intervention of RC1 HL099612 for real-world practice by 1) conducting a randomized controlled trial that compares the Patient Advocate Intervention (PAI) to currently practiced guideline-based usual care; 2) carrying out the intervention in a variety of primary care and asthma specialty practices; 3) extending the observation time to a year to test its sustainability; 4) assessing patient-centered outcomes including asthma control, quality of life, ED visits, and hospitalizations; 5) assessing mediators/moderators of the PAI-asthma outcome relationship; and 6) evaluating its cost-effectiveness.
We will recruit 300 adults, each to be followed for at least 1 year with moderate or severe persistent asthma from clinics serving low-income, urban, primarily minority patients and conduct a randomized controlled trial (RCT) to: 1) assess whether 6 months of the PAI improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion, 2) Assess whether the PAI improves other asthma outcomes (need for prednisone bursts, ED visits, hospitalizations, quality of life, FEV1) relative to baseline compared with UC at 6 months and is sustained in the 6 months following the intervention's completion, 3) examine mediators and moderators of the relationship between the intervention and outcome, 4) assess the incremental direct and indirect costs of the PAI compared to usual care and the cost-effectiveness of the PAI relative to UC for the outcomes, and 5) in post-study focus groups of providers to explore awareness of the intervention and response to the PA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient advocate | Experimental | Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. |
|
| usual care | Other | Patient receives asthma care as usual from their asthma provider |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Advocate | Behavioral | Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control at One Year | Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control. | baseline and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emergency Department(ED) Visits at One Year | Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint | one year |
| Change in Asthma-related Quality of Life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea J Apter, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23800333 | Background | Apter AJ, Wan F, Reisine S, Bogen DK, Rand C, Bender B, Bennett IM, Gonzalez R, Priolo C, Sonnad SS, Bryant-Stephens T, Ferguson M, Boyd RC, Ten Have T, Roy J. Feasibility, acceptability and preliminary effectiveness of patient advocates for improving asthma outcomes in adults. J Asthma. 2013 Oct;50(8):850-60. doi: 10.3109/02770903.2013.812655. Epub 2013 Jul 17. | |
| 23591273 | Background | Apter AJ, Wan F, Reisine S, Bender B, Rand C, Bogen DK, Bennett IM, Bryant-Stephens T, Roy J, Gonzalez R, Priolo C, Have TT, Morales KH. The association of health literacy with adherence and outcomes in moderate-severe asthma. J Allergy Clin Immunol. 2013 Aug;132(2):321-7. doi: 10.1016/j.jaci.2013.02.014. Epub 2013 Apr 13. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Advocate | Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients |
| FG001 | Usual Care | Patient receives asthma care as usual from their asthma provider |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Advocate | Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients |
| 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 | Change in Asthma Control at One Year | Asthma Control Questionnaire: In a randomized controlled trial we will assess whether 6 months of the Patient Advocate Intervention improves asthma control relative to baseline compared with usual care (UC) and whether such a difference is sustained in the 6 months following the intervention's completion. Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control. | 18 years or more, physician's diagnosis of asthma, prescribed an inhaled-steroid for asthma, moderate or severe persistent asthma, evidence of reversible airflow obstruction, at least one appointment scheduled with the asthma physician during the 1st 6 months of participation | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline and 1 year |
|
one year
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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 | Patient Advocate | Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea J Apter, MD | University of Pennsylvania | 215 349-5120 | andrea.apter@uphs.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2013 | Jul 31, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D003142 | Communication |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| Usual Care | Behavioral | Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines |
|
Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life.
| baseline to one year |
| Change in Hospitalizations | Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year. | one year |
| Risk of Prednisone Bursts | a new dose or an increase in already prescribed prednisone dose | baseline and one year |
| Change in Urgent Office Visit | Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit. | one year |
| 26264737 | Background | Apter AJ, Bryant-Stephens T, Morales KH, Wan F, Hardy S, Reed-Wells S, Dominguez M, Gonzalez R, Mak N, Nardi A, Park H, Howell JT, Localio R. Using IT to improve access, communication, and asthma in African American and Hispanic/Latino Adults: Rationale, design, and methods of a randomized controlled trial. Contemp Clin Trials. 2015 Sep;44:119-128. doi: 10.1016/j.cct.2015.08.001. Epub 2015 Aug 8. |
| 27777181 | Background | Bryant-Stephens T, Reed-Wells S, Canales M, Perez L, Rogers M, Localio AR, Apter AJ. Home visits are needed to address asthma health disparities in adults. J Allergy Clin Immunol. 2016 Dec;138(6):1526-1530. doi: 10.1016/j.jaci.2016.10.006. Epub 2016 Oct 21. |
| 27789250 | Background | Kramer CB, LeRoy L, Donahue S, Apter AJ, Bryant-Stephens T, Elder JP, Hamilton WJ, Krishnan JA, Shelef DQ, Stout JW, Sumino K, Teach SJ, Federman AD. Enrolling African-American and Latino patients with asthma in comparative effectiveness research: Lessons learned from 8 patient-centered studies. J Allergy Clin Immunol. 2016 Dec;138(6):1600-1607. doi: 10.1016/j.jaci.2016.10.011. Epub 2016 Oct 24. |
| 32673877 | Background | Apter AJ, Perez L, Han X, Ndicu G, Localio A, Park H, Mullen AN, Klusaritz H, Rogers M, Cidav Z, Bryant-Stephens T, Bender BG, Reisine ST, Morales KH. Patient Advocates for Low-Income Adults with Moderate to Severe Asthma: A Randomized Clinical Trial. J Allergy Clin Immunol Pract. 2020 Nov-Dec;8(10):3466-3473.e11. doi: 10.1016/j.jaip.2020.06.058. Epub 2020 Jul 14. |
| 28499772 | Background | Korwin A, Black H, Perez L, Morales KH, Klusaritz H, Han X, Huang J, Rogers M, Ndicu G, Apter AJ. Exploring Patient Engagement: A Qualitative Analysis of Low-Income Urban Participants in Asthma Research. J Allergy Clin Immunol Pract. 2017 Nov-Dec;5(6):1625-1631.e2. doi: 10.1016/j.jaip.2017.03.022. Epub 2017 May 10. |
| 34785390 | Derived | Buckey TM, Morales KH, Apter AJ. Understanding Autonomy in Patients with Moderate to Severe Asthma. J Allergy Clin Immunol Pract. 2022 Feb;10(2):525-533. doi: 10.1016/j.jaip.2021.10.068. Epub 2021 Nov 14. |
| Death |
|
| BG001 | Usual Care | Patient receives asthma care as usual from their asthma provider |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| asthma control questionnaire | Asthma Control range is 0-6 with lower score better control (0= total control and 6 = extremetly uncontrolled. The minimally important clinical difference is 0.5. A score > 1.5 is considered inadequate control. | Mean | Standard Deviation | units on a scale |
|
Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients. |
| OG001 | Usual Care | Patient receives asthma care as usual from their asthma provider |
|
|
|
| Secondary | Change in Emergency Department(ED) Visits at One Year | Emergency room visits in the 6 months before entry compared with emergency room visits in the 6 months prior to the one year timepoint | Posted | Least Squares Mean | 95% Confidence Interval | visits per 6 months | one year |
|
|
|
|
| Secondary | Change in Asthma-related Quality of Life | Asthma-related quality of life will be measured with the Mini-Asthma Quality of Life Questionnaire (AQLQ). This 15-item questionnaire with each item having a 7-point response scale that provides a mean summary score. A 0.5-unit change is considered clinically meaningful. the range is 1 - 7 with higher score better quality of life. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline to one year |
|
|
|
|
| Secondary | Change in Hospitalizations | Participants will report hospitalizations verified if possible in participating health systems. We review records and if not available ask patient for hospititalizations over the 6 months before baseline and compare it with the record or report in the 6-months prior to one year. | Posted | Least Squares Mean | 95% Confidence Interval | hospitalizations per 6 months | one year |
|
|
|
|
| Secondary | Risk of Prednisone Bursts | a new dose or an increase in already prescribed prednisone dose | Posted | Least Squares Mean | 95% Confidence Interval | risk of prednisone bursts | baseline and one year |
|
|
|
|
| Secondary | Change in Urgent Office Visit | Records or if not available patient report of an urgent office visit in the 6 months before baseline compared with record or report of urgent office visits in the 6 months prior to one year. An urgent office visit is one scheduled within 24 hours of the visit. | Posted | Least Squares Mean | 95% Confidence Interval | urgent visits per 6 months | one year |
|
|
|
|
| 4 |
| 156 |
| 89 |
| 156 |
| 71 |
| 156 |
| EG001 | Usual Care | Patient receives asthma care as usual from their asthma provider Patient Advocate: Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to carrying out medical advice, and transfer of information between providers and patients | 1 | 156 | 90 | 156 | 74 | 156 |
| foot pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| short of breath | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| surgical and medical procedure | Surgical and medical procedures | SAFETY PROFILER | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| chest pain | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| allergic reaction | Immune system disorders | SAFETY PROFILER | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| ankle sprain | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| skin abscess | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| skin infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| headache | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| injury, poisoning and procedural complication | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| hypertension | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| acute sinusitis | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| upper respiratory infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| hyperglycemia | Endocrine disorders | SAFETY PROFILER | Systematic Assessment |
|
| psychiatric disorder | Psychiatric disorders | SAFETY PROFILER | Systematic Assessment |
|
| skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| diverticulitis | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| hypoglycemia | Endocrine disorders | SAFETY PROFILER | Systematic Assessment |
|
| pregnancy | Pregnancy, puerperium and perinatal conditions | SAFETY PROFILER | Systematic Assessment |
|
| bronchial infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| anxiety | Psychiatric disorders | SAFETY PROFILER | Systematic Assessment |
|
| chest wall pain | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| flu-like symptoms | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| fracture | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| gastrointestinal disorders | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| acute and chronic respiratory failure with hypoxia | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| respiratory, thoracic and medistinal disorders | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| seizure | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| skin ulcer | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| urticaria | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| vaginal bleeding | Reproductive system and breast disorders | SAFETY PROFILER | Systematic Assessment |
|
| wheeze | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| lung infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| noncardiac chest pain | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| anaphylaxis | Immune system disorders | SAFETY PROFILER | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | SAFETY PROFILER | Systematic Assessment |
|
| ankle fracture | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| blood and lymphatic system disorders | Blood and lymphatic system disorders | SAFETY PROFILER | Systematic Assessment |
|
| blurred vision | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| bruising | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| colitis | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| conjunctivitis | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | SAFETY PROFILER | Systematic Assessment |
|
| dental caries | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| depression | Psychiatric disorders | SAFETY PROFILER | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| dry mouth | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | SAFETY PROFILER | Systematic Assessment |
|
| corneal abrasion | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| eye irritation | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| facial pain | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| fatigue | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| fever | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| gait disturbance | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| gall bladder pain | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| general disorders | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| immune system disorders | Immune system disorders | SAFETY PROFILER | Systematic Assessment |
|
| knee swelling | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| metabolism and nutrition disorders | Metabolism and nutrition disorders | SAFETY PROFILER | Systematic Assessment |
|
| musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| trigeminal neurlagia | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| ear infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| palpitations | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| paresthesia | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| pleurisy | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| kidney stone | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| reproductive system and breast disorders | Reproductive system and breast disorders | SAFETY PROFILER | Systematic Assessment |
|
| sepsis | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| seroma | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| sleep apnea | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| small intestine obstruction | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| stroke symptoms | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| suicidal ideation | Psychiatric disorders | SAFETY PROFILER | Systematic Assessment |
|
| transient ischemic attack | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| urinary retention | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| uterine pain | Reproductive system and breast disorders | SAFETY PROFILER | Systematic Assessment |
|
| vaginal infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| deep venous thrombosis | Vascular disorders | SAFETY PROFILER | Systematic Assessment |
|
| ventricular arrhrythmia | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| ear and labyrinth disorders | Ear and labyrinth disorders | SAFETY PROFILER | Systematic Assessment |
|
| corneal ulcer | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| infection and infestations | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| edema | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| angina | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| peritoneal infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| sinus disorder | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| soft tissue infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| vulvovaginal candidiasis | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| foot weakness | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| short of breath | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| foot pain | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| depression | Psychiatric disorders | SAFETY PROFILER | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| headache | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| sinusitis | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| skin disorders | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| surgical and medical procedures | Surgical and medical procedures | SAFETY PROFILER | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| chest pain | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| flu-like symptoms | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| allergic reaction | Immune system disorders | SAFETY PROFILER | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| abscess | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| bronchial infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| arthritis | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| hypertension | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| arthralgia shoulder | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| gastrointestinal disorder | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| neoplasm benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SAFETY PROFILER | Systematic Assessment |
|
| ear infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| pain | General disorders | SAFETY PROFILER | Systematic Assessment |
|
| cellulitis | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| palpitations | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| respiratory, thoracic, and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| skin infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| GERD | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| blood and lymphatic system disorders | Blood and lymphatic system disorders | SAFETY PROFILER | Systematic Assessment |
|
| bruising | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| cardiac disorders | Cardiac disorders | SAFETY PROFILER | Systematic Assessment |
|
| chest wall pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | SAFETY PROFILER | Systematic Assessment |
|
| dysphagia | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| ear pain | Ear and labyrinth disorders | SAFETY PROFILER | Systematic Assessment |
|
| diverticulitis | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| hemorroids | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| hyperglycemia | Metabolism and nutrition disorders | SAFETY PROFILER | Systematic Assessment |
|
| injury, poisoning and procedural complications | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| menorrhagia | Reproductive system and breast disorders | SAFETY PROFILER | Systematic Assessment |
|
| pharyngitis | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| pregnancy, puerperium and perinatal conditions | Pregnancy, puerperium and perinatal conditions | SAFETY PROFILER | Systematic Assessment |
|
| presyncope | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| renal and urinary disorders | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| reproductive system and breast disorders | Reproductive system and breast disorders | SAFETY PROFILER | Systematic Assessment |
|
| sinus pain | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| sore throat | Respiratory, thoracic and mediastinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | SAFETY PROFILER | Systematic Assessment |
|
| transient ischemic attack | Nervous system disorders | SAFETY PROFILER | Systematic Assessment |
|
| bladder tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | SAFETY PROFILER | Systematic Assessment |
|
| ear and labyrinth disorders | Ear and labyrinth disorders | SAFETY PROFILER | Systematic Assessment |
|
| corneal ulcer | Eye disorders | SAFETY PROFILER | Systematic Assessment |
|
| infections and infestations | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| wound complication | Injury, poisoning and procedural complications | SAFETY PROFILER | Systematic Assessment |
|
| esophageal infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| lung infection | Infections and infestations | SAFETY PROFILER | Systematic Assessment |
|
| autoimmune disorder | Immune system disorders | SAFETY PROFILER | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| noncardiac chest pain | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| cystitis noninfective | Renal and urinary disorders | SAFETY PROFILER | Systematic Assessment |
|
| papularpustulo rash | Skin and subcutaneous tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
| muscle weakness upper limb | Musculoskeletal and connective tissue disorders | SAFETY PROFILER | Systematic Assessment |
|
Not provided
Not provided
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001519 | Behavior |