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| Name | Class |
|---|---|
| Fenzian Ltd. | UNKNOWN |
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The purpose of this study is to investigate the effects of Fenzian™ treatment on symptoms (such as shortness of breath), lung function (how well the lungs work), and albuterol/salbutamol (rescue medication) use in people with asthma. This will be done by comparing the effects of Fenzian™ treatment to the effects of a sham treatment, which looks the same as the Fenzian™ device but doesn't do anything.
The Fenzian™ device is an electrical instrument that the investigators hope will help reduce airway inflammation associated with asthma symptoms by stimulating the nerves with very low electrical currents. The study device will be applied directly to the skin on the back, working along the ribs toward the spine, alternating between left and right sides, and on your face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fenzian Device | Experimental | Subjects randomized to this arm will receive treatment with the Fenzian Device |
|
| Sham Device | Sham Comparator | Subjects randomized to this arm will receive treatment with the sham device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenzian Device | Device | Three 20-minute treatments with the Fenzian Device per week for 5 weeks (for a total of 15 treatments) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Questionnaire (ACQ) 7 Score | Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry. | Baseline to completion of treatment at 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use | Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day) | 2 weeks after completion of treatment (weeks 9-11) |
| Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days |
Not provided
Inclusion Criteria:
Ages 12-80 years. [NOTE: Only the Johns Hopkins site will enroll subjects under 18.]
Clinical history consistent with asthma (GINA 4 definitions) for at least six months
Current symptoms and features of partly-controlled or uncontrolled asthma, according to GINA classification of asthma control
A stable (1 month) treatment regimen consisting of:
Willingness to comply with the study protocol and ability to perform the study procedures.
Willingness to attend the study site according to the specified treatment schedule
Inclusion Criteria Assessed at Visit 1:
Inclusion Criteria Assessed at Visit 2:
Reversibility of FEV1 of at least 200ml, 15-30 minutes after 4 puffs of albuterol HFA pressurized metered-dose inhaler (pMDI) if not confirmed at Visit 1 plus
Using short-acting bronchodilator therapy on two or more occasions in each of the two weeks preceding Visit 2 plus (Ventolin HFA counter decrease of at least 8 puffs)
Partly controlled or uncontrolled of asthma as indicated by one to three, but not four of the following in each of the two weeks preceding Visit 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher B Cooper, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States | ||
| Johns Hopkins University |
Participants who signed consent and passed screening were enrolled into the study and randomized to a treatment arm. One of 42 active treatment participants withdrew consent after being randomized but prior to receiving treatment. He/she did not provide a reason.
Subjects were recruited at six clinical sites using flyers, newspaper, radio and campus advertising, and by contacting participants of prior studies whom agreed to future contacts. The recruitment period lasted from June 2009 to December 17, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fenzian Device | 20-minute treatments with the Fenzian Device, 3 times per week for 5 weeks (15 treatments total) |
| FG001 | Sham Device | 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fenzian Device | 20-minute treatments with the Fenzian device, 3 times per week for 5 weeks (15 treatments total). |
| BG001 | Sham Device | 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total). |
| 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 | Change in Asthma Control Questionnaire (ACQ) 7 Score | Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms and a question completed by the staff for categorization of the patient/subjects forced expiratory volume in the first second (FEV1) from spirometry. | All subjects who completed Visit 3 (5 weeks of treatment) were included in the analysis. | Posted | Mean | Standard Error | ACQ7 score | Baseline to completion of treatment at 9 weeks |
|
15 weeks for each subject
All reported adverse events, regardless of relatedness to study
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fenzian Device | Subjects randomized to this arm will receive treatment with the Fenzian Device |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma exacerbation | Respiratory, thoracic and mediastinal disorders | MeSH | Non-systematic Assessment | Worsening of asthma |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Kleerup | University of California, Los Angeles | 310-794-6593 | ekleerup@mednet.ucla.edu |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
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| Sham Device | Device | Three 20-minute treatments with the sham device per week for 5 weeks (for a total of 15 treatments) (NOTE: This arm is similar to a placebo arm in a drug trial.) |
|
Percent of rescue-free days during a two week period after completing treatment phase |
| 2 weeks after completion of treatment (weeks 10 -11) |
| Change in Asthma Control Questionnaire 6 Score | Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms. | Baseline to completion of treatment at 9 weeks |
| Change in Spirometry - FEV1 | Baseline to completion of treatment at 9 weeks |
| Change in Spirometry - Forced Vital Capacity (FVC) | Baseline to completion of treatment at 9 weeks |
| Change in Spirometry - FEV1/FVC | Baseline to completion of treatment at 9 weeks |
| Change in Spirometry FEF25-75% | A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%) | Baseline to completion of treatment at 9 weeks |
| Change in Asthma Control Test Score | The Asthma Control Test is a 5-item questionnaire using 1-5 point Likert scales; maximum score 25 = complete control of asthma; minimum score 5 = poor control of asthma. | Baseline to completion of treatment at 9 weeks |
| Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life) | The mini AQLQ is a questionnaire specifically designed to assess health status in patients with asthma. The mini-AQLQ consists of 15 questions covering symptoms and activities. Each question is scaled from 1 (poorly controlled asthma) to 7(maximally controlled asthma) where 7 reflects a higher quality of life. Total score is the sum of 15 items and may range from 15-105. An increase in the AQLQ score indicates a better quality of life. | Baseline to completion of treatment at 9 weeks |
| Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score | The SNOT-22 is a disease-specific quality of life score for rhinosinusitis. SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients. | Baseline to completion of treatment at 9 weeks |
| Change in SNOT-22 Nasal Sub-score | Sino-nasal outcome test-22 nasal sub-score. The nasal subscore consists of 8 questions, each on a scale of 0 (no problems) to 5 (as bad as it can be). Higher scores indicate worse symptoms of rhinosinusitis. | Baseline to completion of treatment at 9 weeks |
| Daytime Symptom Score | Daytime symptoms due to asthma were assessed via the electronic diary (AM2+ Asthma Monitor) each evening for 7 days prior to the study visit at Week 15. Daily scores were derived from five questions relating to 1) frequency of asthma symptoms, 2) impact of asthma symptoms, 3) activity, 4) impact of asthma on activity, and 5) breathlessness. Each question was scored from 0 (best) to 6 (worst), with the average of 5 questions providing a daily score ranging from 0 (best) to 6 (worst). Each participant's symptom score was calculated as the average of 7 daily scores. Thus, the range of possible scores is from 0 (best) to 6 (worst). | 7 days prior to final assessment visit at week 15 |
| Change in Transition Dyspnea Index (TDI) - Functional Impairment | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to completion of treatment at 9 weeks |
| Change in Transition Dyspnea Index - Magnitude of Task at Visit 3 | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to completion of treatment at 9 weeks |
| Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3 | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to completion of treatment at 9 weeks |
| Change in Transition Dyspnea Index - Functional Impairment | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to final assessment visit (15 weeks) |
| Change in Transition Dyspnea Index - Magnitude of Task | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to final assessment visit (15 weeks) |
| Change in Transition Dyspnea Index - Magnitude of Effort | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | Baseline to final assessment visit (15 weeks) |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cape Town Lung Institute | Mowbray | Cape Town | 7700 | South Africa |
| Addenbrookes NHS Trust, Cambridge University | Bottisham | Cambridgeshire | CB2 OQQ | United Kingdom |
| London Chest Hospital | London | England | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sham Device | 20-minute treatments with the sham device, 3 times per week for 5 weeks (15 treatments total). |
|
|
| Secondary | Daily Short-acting Bronchodilator (Albuterol/Salbutamol) Use | Daily short-acting bronchodilator use during the 2 weeks, modeled as a zero-modified negative binomial (usually 2 puffs/day) | All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Deviation | Puffs/day | 2 weeks after completion of treatment (weeks 9-11) |
|
|
|
| Secondary | Short-acting Bronchodilator (Albuterol/Salbutamol) Free Days | Percent of rescue-free days during a two week period after completing treatment phase | All subjects whose short-acting bronchodilator counters were functioning and who completed Visit 3 were included in the analysis | Posted | Mean | 95% Confidence Interval | Percent of days | 2 weeks after completion of treatment (weeks 10 -11) |
|
|
|
| Secondary | Change in Asthma Control Questionnaire 6 Score | Asthma Control Questionnaire (QOL Technologies 2004) Elizabeth Juniper, (Eur Respir J 1999; 14:902-7). Range 0-6, 0 is no symptoms, 6 is maximal symptoms. 0.5 is considered a minimally important difference, 0.75 or less is associated with a 85% chance that the subject's asthma is well controlled, 1.50 or greater is associated with a 88% chance that the subject's asthma is not well controlled. The ACQ consists of 6 patient/subject reported questions on symptoms. | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | ACQ6 score | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Spirometry - FEV1 | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | L | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Spirometry - Forced Vital Capacity (FVC) | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | L | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Spirometry - FEV1/FVC | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | Ratio | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Spirometry FEF25-75% | A measure of forced expiratory flow between 25% and 75% of FVC (FEF25-75%) | All subjects who completed treatment (weeks 5-9) were included in the analysis. | Posted | Mean | Standard Error | L/s | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Asthma Control Test Score | The Asthma Control Test is a 5-item questionnaire using 1-5 point Likert scales; maximum score 25 = complete control of asthma; minimum score 5 = poor control of asthma. | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | ACT score | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Mini Asthma Quality of Life Questionnaire (AQLQ) Score (to Evaluate Quality of Life) | The mini AQLQ is a questionnaire specifically designed to assess health status in patients with asthma. The mini-AQLQ consists of 15 questions covering symptoms and activities. Each question is scaled from 1 (poorly controlled asthma) to 7(maximally controlled asthma) where 7 reflects a higher quality of life. Total score is the sum of 15 items and may range from 15-105. An increase in the AQLQ score indicates a better quality of life. | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Sino-Nasal Outcome Test (SNOT-22) - Total Score | The SNOT-22 is a disease-specific quality of life score for rhinosinusitis. SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients. | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | units on a scale | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in SNOT-22 Nasal Sub-score | Sino-nasal outcome test-22 nasal sub-score. The nasal subscore consists of 8 questions, each on a scale of 0 (no problems) to 5 (as bad as it can be). Higher scores indicate worse symptoms of rhinosinusitis. | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Error | SNOT22 score | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Daytime Symptom Score | Daytime symptoms due to asthma were assessed via the electronic diary (AM2+ Asthma Monitor) each evening for 7 days prior to the study visit at Week 15. Daily scores were derived from five questions relating to 1) frequency of asthma symptoms, 2) impact of asthma symptoms, 3) activity, 4) impact of asthma on activity, and 5) breathlessness. Each question was scored from 0 (best) to 6 (worst), with the average of 5 questions providing a daily score ranging from 0 (best) to 6 (worst). Each participant's symptom score was calculated as the average of 7 daily scores. Thus, the range of possible scores is from 0 (best) to 6 (worst). | All subjects whose diaries were functioning and who completed diary assessments and completed Visit 3 were included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | 7 days prior to final assessment visit at week 15 |
|
|
|
| Secondary | Change in Transition Dyspnea Index (TDI) - Functional Impairment | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Transition Dyspnea Index - Magnitude of Task at Visit 3 | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Transition Dyspnea Index - Magnitude of Effort at Visit 3 | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 3 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to completion of treatment at 9 weeks |
|
|
|
| Secondary | Change in Transition Dyspnea Index - Functional Impairment | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 4 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to final assessment visit (15 weeks) |
|
|
|
| Secondary | Change in Transition Dyspnea Index - Magnitude of Task | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 4 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to final assessment visit (15 weeks) |
|
|
|
| Secondary | Change in Transition Dyspnea Index - Magnitude of Effort | The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI category scores range from -3 (major deterioration) to +3 (major improvement) | All subjects who completed Visit 4 were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline to final assessment visit (15 weeks) |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 28 |
| 40 |
| EG001 | Sham Device | Subjects randomized to this arm will receive treatment with the sham device. | 0 | 39 | 0 | 39 | 21 | 39 |
|
| Other dyspnea | Respiratory, thoracic and mediastinal disorders | MeSH | Non-systematic Assessment |
|
| Upper respiratory infections | Respiratory, thoracic and mediastinal disorders | MeSH | Non-systematic Assessment |
|
| Other infection | Infections and infestations | MeSH | Non-systematic Assessment | One of each of the following: Conjunctivitis, Infected scalp lesion, fungal fingernail infection, Otitis media (ear infection), urinary tract infection |
|
| Candidiasis, Oral | Infections and infestations | MeSH | Non-systematic Assessment |
|
| Exanthema | Skin and subcutaneous tissue disorders | MeSH | Non-systematic Assessment | Skin rash |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MeSH | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MeSH | Non-systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | MeSH | Non-systematic Assessment |
|
| Edema | Skin and subcutaneous tissue disorders | MeSH | Non-systematic Assessment | Pedal edema |
|
| Abdominal pain | Gastrointestinal disorders | MeSH | Non-systematic Assessment |
|
| Diabetes Mellitus, Type 2 | Endocrine disorders | MeSH | Non-systematic Assessment |
|
| Weight loss | General disorders | MeSH | Non-systematic Assessment |
|
| Central Nervous System Disorders | Nervous system disorders | MeSH | Non-systematic Assessment | Dizziness, anxiety, headache |
|
| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MeSH | Non-systematic Assessment | Lower respiratory tract infection |
|
The University (the PI) must furnish the Sponsor with a copy of any proposed written or oral publication (including manuscripts, abstracts, and oral presentations) at least 30 days prior to submission for publication. The Sponsor can direct the PI to delete their confidential information. The information contained in this results section was provided to the Sponsor 30 days ago and they have not asked for any deletions.
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |