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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab (Lucentis) in subjects with DME (diabetic macular edema) previously treated with intravitreal bevacizumab (Avastin) with a randomized comparative dosing strategy, monthly vs "treat-and-extend." Thirty patients total will be enrolled in the study, 15 in each group. This study will have a 1-year treatment period. The recruitment period will occur over 1 year with total potential study duration of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I - Monthly | Other | Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. |
|
| Group II - Treat-and-Extend | Other | Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-severe Ocular Adverse Events | As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | 12 months |
| Number of Participants With Severe Ocular Adverse Events | As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. | 12 months |
| Number of Participants With Non-severe Non-ocular Adverse Event | As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | 12 months |
| Number of Participants With Severe Non-ocular Adverse Event | As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in BCVA | Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12. | Months 6 and 12 |
| Mean Change in Central Foveal Thickness |
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Inclusion Criteria:
Subjects will be eligible if the following criteria are met:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from this study:
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| Name | Affiliation | Role |
|---|---|---|
| Justis Ehlers, M.D. | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cole Eye Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | United States | ||
| Cole Eye Institute at Hillcrest Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I - Monthly | Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema. |
| FG001 | Group II - Treat-and-Extend | Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I - Monthly | Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema. |
| 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 | Number of Participants With Non-severe Ocular Adverse Events | As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | Patients who exited the study early were accounted by using a last observation carried forward approach. | Posted | Count of Participants | Participants | 12 months |
|
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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 | Group I - Monthly | Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. Ranibizumab: Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of Chronic Kidney Disease | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased Vision | Eye disorders | Non-systematic Assessment |
The relatively small sample size of eyes and short 1 year duration makes it challenging to extrapolate data to generate clinical management guidelines. The lack of a control group is an important limitation to recognize that also limits conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Justis Ehlers | Cleveland Clinic Foundation | 216-636-0183 | Ehlersj@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 27, 2017 | Aug 13, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 7, 2013 | Aug 30, 2019 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Ranibizumab | Drug | Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. |
|
|
Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)
| Months 6 and 12 |
| Anatomically Dry Eyes by SDOCT | Number of participants with an anatomically "dry" study eye by SDOCT at months 6 and 12 | Months 6 and 12 |
| Gain in Vision Greater Than or Equal to 15 Letters | Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12. | Months 6 and 12 |
| Loss in Vision Greater Than or Equal to 15 Letters | Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12. | Months 6 and 12 |
| Participants With BCVA at 20/40 or Better | Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12. | Months 6 and 12 |
| Number of Participants With Angiographic Leakage | Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage). | 3, 6 and 12 months |
| Number of Participants With Nonperfusion | Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia). | 3, 6 and 12 months |
| Mayfield Heights |
| Ohio |
| 44124 |
| United States |
| BG001 |
| Group II - Treat-and-Extend |
Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Group II - Treat-and-Extend | Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. |
|
|
|
| Primary | Number of Participants With Severe Ocular Adverse Events | As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Number of Participants With Non-severe Non-ocular Adverse Event | As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Primary | Number of Participants With Severe Non-ocular Adverse Event | As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Mean Change in BCVA | Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12. | Posted | Mean | Standard Deviation | ETDRS letters | Months 6 and 12 |
|
|
|
| Secondary | Mean Change in Central Foveal Thickness | Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield) | Posted | Mean | Standard Deviation | microns | Months 6 and 12 |
|
|
|
| Secondary | Anatomically Dry Eyes by SDOCT | Number of participants with an anatomically "dry" study eye by SDOCT at months 6 and 12 | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Gain in Vision Greater Than or Equal to 15 Letters | Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12. | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Loss in Vision Greater Than or Equal to 15 Letters | Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12. | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Participants With BCVA at 20/40 or Better | Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12. | Posted | Count of Participants | Participants | Months 6 and 12 |
|
|
|
| Secondary | Number of Participants With Angiographic Leakage | Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage). | Posted | Count of Participants | Participants | 3, 6 and 12 months |
|
|
|
| Secondary | Number of Participants With Nonperfusion | Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia). | Posted | Count of Participants | Participants | 3, 6 and 12 months |
|
|
|
| 0 |
| 15 |
| 6 |
| 15 |
| 15 |
| 15 |
| EG001 | Group II - Treat-and-Extend | Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. Ranibizumab: Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. | 0 | 12 | 3 | 12 | 12 | 12 |
| POSSIBLE CELLULITIS TO RIGHT LOWER EXTREMITY | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| TRANSIENT ISCHEMIC ATTACK | Cardiac disorders | Systematic Assessment |
|
| ACUTE INFARCT STROKE | Cardiac disorders | Systematic Assessment |
|
| UNSTABLE ANGINA AND CHEST PAIN | Cardiac disorders | Systematic Assessment |
|
| VERTIGO | General disorders | Systematic Assessment |
|
| LARGE OVARIAN NEOPLASM | Reproductive system and breast disorders | Systematic Assessment |
|
| HOSPITALIZED FOR PERITONITIS | Renal and urinary disorders | Systematic Assessment |
|
| HOSPITALIZED FOR ANGINA/SOB | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| HOSPITALIZED FOR DIABETIC RIGHT HEEL ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| HOSPITALIZED FORCONFUSION/SLURRED SPEECH AFTER FALL | Social circumstances | Non-systematic Assessment |
|
| HOSPITALIZED FOR RECURRENT SOB, LEG EDEMA | General disorders | Systematic Assessment |
|
| HOSPITALIZATION FOR GANGRENE | Infections and infestations | Systematic Assessment |
|
| HOSPITALIZATION R DIABETIC FOOT ULCER INFECTION | Infections and infestations | Systematic Assessment |
|
| HOSPITALIZATION FOR TOTAL HYSTERECTOMY | Reproductive system and breast disorders | Systematic Assessment |
|
| HOSPITALIZATION FOR HYPERKALEMIA | Endocrine disorders | Systematic Assessment |
|
| HOSPITALIZATION FOR GANGRENE/AMPUTATION | Infections and infestations | Systematic Assessment |
|
| HOSPITALIZATION FOR OSTEOMYELITIS/AMPUTATION | Infections and infestations | Systematic Assessment |
|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Flu-like symptoms | General disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Difficulty with reading | Eye disorders | Non-systematic Assessment |
|
| Difficulty with driving | General disorders | Non-systematic Assessment |
|
| Hyperglycemic episode | General disorders | Systematic Assessment |
|
| Edema | Vascular disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Worsening of diabetes | Renal and urinary disorders | Systematic Assessment |
|
| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
|
| Foreign Body Sensation | Eye disorders | Systematic Assessment |
|
| Hypoglycemic episode | General disorders | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Stye | Eye disorders | Systematic Assessment |
|
| Diplopia | Eye disorders | Systematic Assessment |
|
| Urinary Tract infection | Renal and urinary disorders | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain from fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Generalized rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Thyroid cancer | General disorders | Systematic Assessment |
|
| Uterine cancer suspect | Reproductive system and breast disorders | Systematic Assessment |
|
| Bladder cancer | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Epiretinal Membrane | Eye disorders | Systematic Assessment |
|
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vitamin Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Elevated microalbumin | General disorders | Systematic Assessment |
|
| Ocular irritation | Eye disorders | Non-systematic Assessment |
|
| Eye Discharge | Eye disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Generalized weakness | General disorders | Non-systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Anemia | General disorders | Systematic Assessment |
|
| Benign polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Thalassemia Trait | Blood and lymphatic system disorders | Systematic Assessment |
|
| Optic neuropathy | Eye disorders | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Atherosclerosis | Vascular disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Elevated Creatinine levels | General disorders | Systematic Assessment |
|
| Sun damage | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated d-Dimer | General disorders | Systematic Assessment |
|
| Hypomagnesemia | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Thyroid nodule | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| OSA Worsening | General disorders | Non-systematic Assessment |
|
| Nausea | General disorders | Non-systematic Assessment |
|
| Worsening of cataracts | Eye disorders | Systematic Assessment |
|
| Cold Sore | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hyperlipidemia | General disorders | Systematic Assessment |
|
| Glare in vision | Eye disorders | Non-systematic Assessment |
|
| Elevated INR | General disorders | Systematic Assessment |
|
| Pruritus after fluorescein dye | General disorders | Systematic Assessment |
|
| Asymptomatic Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Foot pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bullous eruption on glans | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pruritus on neck | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Insomnia - worsening | General disorders | Systematic Assessment |
|
| Posterior Vitreous Detachment | Eye disorders | Systematic Assessment |
|
| Hyperkalemia | General disorders | Systematic Assessment |
|
| Ptosis | Eye disorders | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ocular swelling | Eye disorders | Systematic Assessment |
|
| Medicamentosa suspect | General disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Chronic angle closure glaucoma | Eye disorders | Systematic Assessment |
|
| Lower extremity sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Subconjunctival Hemorrhage | Eye disorders | Systematic Assessment |
|
| Tingling sensation in feet | General disorders | Systematic Assessment |
|
| Puncture wound | Eye disorders | Systematic Assessment |
|
| Elevated Heart Rate | Cardiac disorders | Systematic Assessment |
|
| Elevated FBS | General disorders | Systematic Assessment |
|
| Staph infection of wound on ankle | Infections and infestations | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Difficulty with watching television | Eye disorders | Non-systematic Assessment |
|
| Addison's Disease worsening | General disorders | Systematic Assessment |
|
| Worsening of trigger finger | General disorders | Systematic Assessment |
|
| Elevated TSH levels | General disorders | Systematic Assessment |
|
| SOB episode - allergy to Zanaflex | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Gastrointestinal adverse event |
|
| General adverse event |
|
| Infectious advsere event |
|
| Metabolic adverse event |
|
| Musculoskeletal adverse event |
|
| Cyst, polyp and tumor adverse event |
|
| Nervous system adverse event |
|
| Psychiatric adverse event |
|
| Renal and urinary adverse event |
|
| Reproductive adverse event |
|
| Respiratory adverse event |
|
| Skin and subcutaneous adverse event |
|
| Vascular adverse event |
|
| Stroke |
|
| 12 month |
|
| 12 months |
|