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Phase III clinical study to evaluate the efficacy, expressed as improvement in visual acuity in patients suffering diabetic macular edema after one year of treatment with PRO-169, compared to treatment with Lucentis® (ranibizumab).
A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with either PRO-169 (bevacizumab) or Lucentis® (ranibizumab). There will be a total of 14 visits, including selection and final visits. Monthly evaluations will include ophthalmologic evaluations of anterior and posterior segments, as well as OCT (optic coherence tomography) to obtain central macular width and retinal volume. Fluorescein angiography will be performed on selection visit as well as 6 and 12 months into the study (visits 7 and 13). All patients will be exposed to intravitreal injection of either of the studied drugs monthly for the first 4 months. Starting on visit 5 patients will be injected depending on their response to treatment, calculated according predetermined algorithms including clinical and image variables. Starting on month 6, patients may be subjected to rescue therapy with photocoagulation if they comply with predetermined criteria for such measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-169 | Experimental | Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. |
|
| Lucentis ® | Active Comparator | Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab | Biological | Administration of monthly intravitreal bevacizumab (4-12 injections) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Best Corrected Visual Acuity Area Under the Curve | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values. | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SalaUno Salud, S.A.P.I. de C.V. | Mexico City | 06030 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40750915 | Derived | Salcedo-Villanueva G, Garcia-Sanchez G, Palacio-Pastrana C, Gascon-Guzman G, Moreno-Andrade A, Olvera-Montano O, Munoz-Villegas P. One-year results of visual response following intravitreal novel anti-VEGF injection for diabetic macular edema in a Latino population. Int J Retina Vitreous. 2025 Aug 1;11(1):89. doi: 10.1186/s40942-025-00719-9. | |
| 37543959 |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-169 | Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections) |
| FG001 | Lucentis ® | Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic and baseline characteristics were analyzed in the intention-to-treat population (ITT)
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-169 | Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections) |
| 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 | Best Corrected Visual Acuity | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | The change was obtained from the corresponding visit with respect to the final visit. That is, the change from the baseline visit to visit 1, from the baseline visit to visit 2. | Posted | Mean | Standard Deviation | Letters | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
Adverse events were recorded from the screening visit until the end of follow-up, up to 363 days.
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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 | PRO-169 | Bevacizumab 1.25 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Bevacizumab: Administration of monthly intravitreal bevacizumab (4-12 injections) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alejandra Sanchez-RÃos M.D. | Laboratorios Sophia | :+52 (33) 3001 4200 | alejandra.sanchez@sophia.com.mx |
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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 | Mar 17, 2023 | Mar 26, 2026 | Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Clinical study, phase III, multi-centric, randomized, double-blind, with active parallel control to show non-inferiority.
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| Lucentis® |
| Biological |
Administration of monthly intravitreal ranibizumab (4-12 injections) |
|
| Best Corrected Visual Acuity | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value. | Day 120±3 (Visit 5) |
| Central Macular Thickness | Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
| Retinal Volume | Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | Day 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit) |
| Percentage of Patients With a Positive Response to Treatment. | Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness < 300 μm in men and < 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit). | Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
| Mean Number of Injections | Determining the mean number of injections applied during study, comparing both arms. | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
| Frequency of Rescue Therapy Administration | Number of patients who required photocoagulation treatment | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
| Adverse Events Related to the Injection | This section describes the treatment-related adverse events reported throughout the study | Day 360±3 (Final Visit) |
| Ophthalmic Drug-related Adverse Events | The number of adverse events related to the eyes associated with the medication is described. | Day 360±3 (Final Visit) |
| Systemic Drug-related Adverse Events | The number of treatment-related adverse events at the systemic level is described | Day 360±3 (Final Visit) |
| Torres-Arellano JM, Tornero-Jimenez A, Sanchez-Rios A, Olvera-Montano O, Munoz-Villegas P. Evaluation of the Relationship Between Diabetic Macular Edema and Renal Function in a Latino Population. Ophthalmol Ther. 2023 Oct;12(5):2745-2755. doi: 10.1007/s40123-023-00787-w. Epub 2023 Aug 6. |
| BG001 | Lucentis ® | Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HbA1c [%] | Mean | Standard Deviation | percentage of HbA1c |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Waist circumference | Mean | Standard Deviation | centimeters |
|
| Diabetes mellitus | The length of time a participant has had a diagnosis of diabetes mellitus | Mean | Standard Deviation | years |
|
| Diabetic macular edema | The duration of a participant's diagnosis of diabetic macular edema | Mean | Standard Deviation | years |
|
| Best-corrected visual acuity | Best-corrected visual acuity using the ETDRS chart | Mean | Standard Deviation | letters |
|
| Best-corrected visual acuity (LogMAR) | Best-corrected visual acuity in logMAR | Mean | Standard Deviation | LogMAR |
|
| Central macular thickness | Mean | Standard Deviation | micrometers |
|
| Central volume of the retina | Mean | Standard Deviation | cubic millimeter |
|
| Intraocular pressure | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| OG001 | Lucentis ® | Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections) |
|
|
|
| Secondary | Best Corrected Visual Acuity Area Under the Curve | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The area under the curve of both treatments will be used evaluated as difference between baseline and final (12 months) values. | The analysis of secondary efficacy variables was conducted in the per-protocol population (PP) | Posted | Mean | Standard Deviation | Letters*day | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
|
|
| Secondary | Best Corrected Visual Acuity | Best Corrected Visual Acuity will be evaluated according the standardized ETDRS. The corrected BCVA (adjusted to baseline value) of both treatments will be used evaluated at 4 months. The value was obtained from the value obtained on day 120 minus the baseline value. | The analysis of secondary efficacy variables was conducted in the per-protocol population | Posted | Mean | Standard Deviation | Letters | Day 120±3 (Visit 5) |
|
|
|
| Secondary | Central Macular Thickness | Central macular thickness will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | The analysis of the secondary efficacy variables was conducted in the PP population | Posted | Mean | Standard Deviation | μm | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
|
|
| Secondary | Retinal Volume | Retinal volume will be evaluated through OCT scan. The mean change between two treatments will be used evaluated as difference between baseline and final (12 months) values. | The analysis of the secondary efficacy variables was conducted in the PP population, | Posted | Mean | Standard Deviation | mm^3 | Day 30±3 (Visit 2), 60±3 (Visit 3), 90±3 (Visit 4), 120±3 (Visit 5), 150±3 (Visit 6), 180±3 (Visit 7), 210±3 (Visit 8), 240±3 (Visit 9), 270±3 (Visit 10), 300±3 (Visit 11), 330±3 (Visit 12), 360±3 (Final Visit) |
|
|
|
| Secondary | Percentage of Patients With a Positive Response to Treatment. | Determining the percentage of patients with a positive response to treatment, considered as: absolute improvement (20/20 vision for two consecutive visits and central macular thickness < 300 μm in men and < 290 μm in women), improvement (one or more of the following: patient who gained 5 or more letters for BCVA, ≥ 10% decrease of macular central thickness value compared to last two visits) and stability (one or more of the following: patient with neither a gain of 5 or more letters for BCVA nor a ≥ 10% decrease of macular central thickness value compared to last two visits, patient without loss of 5 or more letters for BCVA or a ≥ 10% decrease of macular central thickness value compared to last visit). | The analysis of secondary efficacy variables was conducted in the per-protocol population (PP). | Posted | Count of Participants | Participants | Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
|
|
| Secondary | Mean Number of Injections | Determining the mean number of injections applied during study, comparing both arms. | The analysis of the secondary efficacy variables was conducted in the PP population, | Posted | Mean | Standard Deviation | injection | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
|
|
| Secondary | Frequency of Rescue Therapy Administration | Number of patients who required photocoagulation treatment | The analysis of secondary efficacy variables was conducted in the per-protocol population (PP) | Posted | Count of Participants | Participants | Day 30±3 (Visit 2), Day 60±3 (Visit 3), Day 90±3 (Visit 4), Day 120±3 (Visit 5), Day 150±3 (Visit 6), Day 180±3 (Visit 7), Day 210±3 (Visit 8), Day 240±3 (Visit 9), Day 270±3 (Visit 10), Day 300±3 (Visit 11), Day 330±3 (Visit 12), Day 360±3 (Final Visit) |
|
|
|
| Secondary | Adverse Events Related to the Injection | This section describes the treatment-related adverse events reported throughout the study | This result was evaluated in the safety population, which consists of subjects who received at least one dose of the treatment | Posted | Number | number of events | Day 360±3 (Final Visit) |
|
|
|
| Secondary | Ophthalmic Drug-related Adverse Events | The number of adverse events related to the eyes associated with the medication is described. | This result was evaluated in the safety population, which consists of subjects who received at least one dose of the treatment | Posted | Number | number of events | Day 360±3 (Final Visit) |
|
|
|
| Secondary | Systemic Drug-related Adverse Events | The number of treatment-related adverse events at the systemic level is described | Posted | Number | number of events | Day 360±3 (Final Visit) |
|
|
|
| 2 |
| 255 |
| 2 |
| 255 |
| 114 |
| 255 |
| EG001 | Lucentis ® | Ranibizumab 0.5 mg / 0.05mL for intravitreal injection. All patients in this arm will be exposed to one monthly injection for the first four months. During the rest of the study, during the monthly visits, it will be decided if injections are to be continued or postponed. The maximum amount of intravitreal injections to be administered are 12. Lucentis®: Administration of monthly intravitreal ranibizumab (4-12 injections) | 3 | 254 | 3 | 254 | 103 | 254 |
| Urinary tract infection Septic shock | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Other | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | It was not possible to determine the EA due to loss of follow-up |
|
| Fluctuations in blood glucose levels | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Elevated glycated hemoglobin | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| High blood pressure | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Elevated intraocular pressure | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Reduced glomerular filtration rate | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacterial conjunctivitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral conjunctivitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Dengue | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacterial pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Ophthalmic herpes | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Bacterial infection of the respiratory tract | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| tooth infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Upper respiratory tract viral infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sepsis resulting from a wound | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Suspected COVID-19 | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Bleeding from the vascular access site | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Heatstroke | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Thermal burns of the eye | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Squamous cell carcinoma of the vagina | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Clear cell endometrial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
|
| Retinal surgery | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Photocoagulation | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Vitrectomy | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
| Angina | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Unstable angina | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Heart failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Alport syndrome | Congenital, familial and genetic disorders | MedDRA (10.0) | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Itching at the injection site | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ingrown toenail | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypercholesterolemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Allergy to contrast dye | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Transient ischemic attack | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Neuritis | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Thoracic outlet syndrome | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Disorder of the nervous system | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypoglycemia | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain in the upper abdomen | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hemorrhagic gastritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Food poisoning | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vascular access complication | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain at the injection site | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pain at the puncture site | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Facial swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral edema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Leakage at the infusion site | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Discomfort at the injection site | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gallstone | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint contracture | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Backache | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Decreased visual acuity | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Floating cells in the vitreous humor | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctivochalasis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Macular degeneration | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal pigment epithelium tear | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rhegmatogenous retinal detachment | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Detachment of the vitreous body | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eyelid eczema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Macular edema | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctival hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vitreous hemorrhage | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctival hyperemia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Conjunctival irritation | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Macular ischemia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye discomfort | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Retinal Artery Occlusion | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Parophthalmia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Itchy eye | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Eye cyst | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vitritis | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Xerophthalmia | Eye disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Anxiety disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Urinary stone | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Kidney failure | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertensive emergency | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Peripheral venous disease | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Inadequately controlled blood pressure | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Varicose ulceration | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Not provided
Not provided
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Visit 4 |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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| Visit 9 |
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| Visit 10 |
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| Visit 11 |
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| Visit 12 |
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| Visit 13 |
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| Visit 4 |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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| Visit 9 |
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| Visit 10 |
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| Visit 11 |
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| Visit 12 |
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| Visit 13 |
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| Visit 4 |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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| Vist 9 |
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| Visit 10 |
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| Visit 11 |
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| Visit 12 |
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| Visit 13 |
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| Stability |
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| Other |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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| Visit 9 |
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| Visit 10 |
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| Visit 11 |
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| Visit 12 |
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| Visit 13 |
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