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This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.
Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LFG316 higher dose | Experimental | LFG316 10 mg/100 μL |
|
| Sham | Sham Comparator | Sham injection |
|
| LFG316 lower dose | Experimental | LFG316 5 mg/ 50 μL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LFG316 | Drug | LFG316 5 mg/50 μL solution for IVT injection, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 | Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505. | Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505) |
| Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence | Number is the Estimated Difference (95% CI) in lesion size. | The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective |
| Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD). | This primary outcome (for Part B) is reported under the Adverse Events section. | Day 1 to Day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence | Mean change in GA lesion growth from baseline to Day 169 and Day 505. | Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505) |
| Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85014 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314061 | Derived | Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Study conducted in 2 parts: Part A & Part B.
Part A evaluated safety & efficacy of multiple 5 mg/50 µL doses of intravitreal (IVT) LFG316 against sham every 28 days for 505 days
Part B evaluated the safety and pharmacokinetics of a single IVT dose of 10 mg/100 µL of LFG316
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| ID | Title | Description |
|---|---|---|
| FG000 | LFG316 | |
| FG001 | Sham |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part A |
|
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| Sham |
| Drug |
Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given) |
|
| LFG316 Lower dose | Drug | LFG316 5 mg/50 μL solution for IVT Injection |
|
Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY |
| Baseline Day 1, Day 169, Day 337 to Day 505 |
| Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW | Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW | Baseline Day 1, Day 169, Day 337 to Day 505 |
| Part A: Concentrations of Total LFG316 in Blood During the Course of the Study | Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream | Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) |
| Part A: Concentrations of Total C5 in Blood During the Course of the Study | Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time | Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) |
| Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters | Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=scheduled sampling time | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
| Tmax (hr) | PART B: Tmax (Time of Maximum concentration observed) This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug. | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
| Part B: Cmax - Summary Statistic for PK Parameters | Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
| Part B: Cmax_D - Summary Statistic for PK Parameters | Cmax_D=ng/mL/mg | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Novartis Investigative Site | Tucson | Arizona | 85704-5614 | United States |
| Novartis Investigative Site | Beverly Hills | California | 90211 | United States |
| Novartis Investigative Site | Pasadena | California | 91105-3153 | United States |
| Novartis Investigative Site | Sacramento | California | 95841 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80909 | United States |
| Novartis Investigative Site | Fort Myers | Florida | 33912-7125 | United States |
| Novartis Investigative Site | Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Winter Haven | Florida | 33880 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30342 | United States |
| Novartis Investigative Site | Leawood | Kansas | 66211 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | United States |
| Novartis Investigative Site | Grand Rapids | Michigan | 49546 | United States |
| Novartis Investigative Site | Jackson | Michigan | 49202 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Novartis Investigative Site | Cleveland | Ohio | 44122 | United States |
| Novartis Investigative Site | Silverdale | Washington | 98383 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Part B |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A- LFG316 5 mg | LFG316 5 mg injection every 28 days for a total of 12 injections |
| BG001 | Part A- Sham | sham injection every 28 days for a total of 12 injections |
| BG002 | Part B- LFG316 10 mg | Single LFG316 10 mg Injection |
| BG003 | Part B- Sham | Single Sham injection |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | PART A (N=99, 51), LFG316 (5 mg/50 µL), sham injection every 28 days for 505 days. PART B (N=7, 1), LFG316 (10 mg/100 µL), single sham injection | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | PART A (N=99, 51), LFG316 (50 mg/50 µL), sham injection every 28 days for 505 days. PART B (N=7, 1), LFG316 (10 mg/100 µL), single sham injection | Count of Participants | 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 | Part A: Geographic Atrophy (GA) Lesion Growth Measured by Fundus Autofluorescence (FAF) From Baseline to Day 505 | Geographic atrophy (GA) lesion growth measured by fundus autofluorescence (FAF) from baseline to Day 505. | Pharmacodynamic analysis set (PD) which includes all patients with at least one dose of study drug and evaluable PD data. | Posted | Mean | Standard Deviation | mm^2 | Day 1 to Day 505 (starting from the day of first intravitreal injection until Day 505) |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Part A: Change From Baseline in GA Lesions Growth Measured by Fundus Autofluorescence | Mean change in GA lesion growth from baseline to Day 169 and Day 505. | PD Set which included patients who had at least one dose of study drug and had evaluable PD Data. | Posted | Mean | Standard Deviation | mm^2 | Day 1 to Day 169 and Day 505 (starting from the day of first intravitreal injection until Day 505) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part A: Change in Best Corrected Visual Acuity (BCVA) as Measured by the EDTRS (Early Treatment of Diabetic Retinopathy Study) Scale From Baseline to Days 169, 337 & 505 in Patients Receiving Every 28 Days, Successive IVT Doses of LFG316 Compared to Sham | Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: STUDY | PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data. | Posted | Mean | Standard Deviation | ETDRS letters | Baseline Day 1, Day 169, Day 337 to Day 505 |
|
| |||||||||||||||||||||||||||||
| Secondary | Part A: Summary of Best Corrected Visual Acuity Over Time, Statistical Analysis of Change in Best Corrected Visual Acuity Over Time Parameter: Visual Acuity (EDTRS Letter) BCVA Scale is 0-100, Worst is 0 and Best 100 Eye: FELLOW | Part A: Summary of best corrected visual acuity over time, statistical analysis of change in best corrected visual acuity over time Parameter: Visual Acuity (EDTRS letter) BCVA scale is 0-100, worst is 0 and best 100 Eye: FELLOW | PD analysis set which includes all patients with at least one dose of study drug and evaluable PD data. | Posted | Mean | Standard Deviation | ETDRS Letters | Baseline Day 1, Day 169, Day 337 to Day 505 |
|
| |||||||||||||||||||||||||||||
| Secondary | Part A: Concentrations of Total LFG316 in Blood During the Course of the Study | Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=hours after the last administered dose e.g.; 0.0 means just before dosing. If the mean concentration is 0.00, that means there is no drug in the bloodstream | Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part A: Concentrations of Total C5 in Blood During the Course of the Study | Summary statistic of total C5 concentrations n=number of participants, h=scheduled sampling time | PD Analysis includes patients who received at least one dose of study drug with evaluable PD data. | Posted | Mean | Standard Deviation | ng/mL | Day 1 to Day 559 (starting from the day of first intravitreal injection to day 559) |
|
| |||||||||||||||||||||||||||||
| Primary | Part A: Sensitivity Analysis of the Primary End Point: Mixed Effects Model for Repeated Measurements on GA Lesion Growth Measured by Fundus Autoflourescence | Number is the Estimated Difference (95% CI) in lesion size. | PD Set which included patients who had at least one dose of study drug and had evaluable PD Data. | Posted | Mean | 95% Confidence Interval | mm^2 | The primary objective was from Day 1 to Day 337, however data was captured to Day 505 as exploratory objective |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B: AUC (Area Under the Curve) - Summary Statistics for PK Parameters | Summary statistic of total LFG316 concentrations (pharmacokinetic analysis set) n=number of participants, h=scheduled sampling time | Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
|
| |||||||||||||||||||||||||||||
| Primary | Part B: Safety and Tolerability of a Single Intravitreal (IVT) Dose of 10 mg/100 μL of LFG316 in Patients With Advanced AMD). | This primary outcome (for Part B) is reported under the Adverse Events section. | Posted | Number | number of patients | Day 1 to Day 85 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Tmax (hr) | PART B: Tmax (Time of Maximum concentration observed) This is the highest concentration of drug in the blood that is measured after a dose. Cmax usually happens within a few hours after the dose is taken. The time that Cmax happens is referred to as Tmax. For some antiretroviral drugs, a high Cmax is thought to increase the risk of side effects from the drug. | Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data. | Posted | Median | Full Range | hours | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B: Cmax - Summary Statistic for PK Parameters | Summary statistic for Part B of total LFG316 concentrations (pharmacokinetic analysis set) Cmax is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose | Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
|
| |||||||||||||||||||||||||||||
| Secondary | Part B: Cmax_D - Summary Statistic for PK Parameters | Cmax_D=ng/mL/mg | Pharmacokinetic analysis set: The PK analysis set included all patients with at least one dose of study drug and evaluable PK data. | Posted | Mean | Standard Deviation | ng/mL/mg | Day 1 to Day 85 (starting from the day of first intravitreal injection to day 85) |
|
|
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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 | Part A - LFG316 5mg | Part A - LFG316 5 mg/50 µL injection every 4 weeks for 18 months | 27 | 99 | 98 | 99 | ||
| EG001 | Part A - Sham | sham injection every 4 weeks for a total of 18 injections | 11 | 51 | 42 | 51 | ||
| EG002 | Part B - LFG316 10mg | Part B - Single LFG316 10 mg/100 µL injection | 1 | 7 | 4 | 7 | ||
| EG003 | Part B - Sham | single sham injection | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Endophthalmitis (Study Eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Auricular haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Plasma cell myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute prerenal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Lung consolidation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Temporal arteritis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Increased tendency to bruise | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Macrocytosis | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Splenomegaly | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Heart valve incompetence | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Corneal dystrophy (Fellow Eye) | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Corneal dystrophy (Study Eye) | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Systematic Assessment |
| |
| Anterior chamber cell (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Anterior chamber flare (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Blepharitis (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Blepharitis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Blepharitis allergic (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Blepharospasm (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract nuclear (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract nuclear (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract subcapsular (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract subcapsular (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Charles Bonnet syndrome | Eye disorders | MedDRA | Systematic Assessment |
| |
| Charles Bonnet syndrome (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Charles Bonnet syndrome (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Chorioretinal atrophy (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Chorioretinal atrophy (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Choroidal neovascularisation (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Choroidal neovascularisation (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival hyperaemia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival oedema (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival vascular disorder (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Corneal deposits (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Corneal oedema (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Corneal opacity (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Corneal scar (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diplopia (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Diplopia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ectropion (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Erythema of eyelid (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Exfoliation glaucoma (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye colour change (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye inflammation (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye irritation (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pruritus (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pruritus (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye swelling (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid irritation (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid oedema (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelids pruritus (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Foreign body sensation in eyes (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Glaucoma (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Hyphaema (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Iritis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Keratitis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Lacrimation decreased (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Lacrimation increased (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Macular degeneration (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Macular oedema (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Neovascular age-related macular degeneration (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Neovascular age-related macular degeneration (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular discomfort (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular hyperaemia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Optic disc disorder (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Optic disc haemorrhage (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Photophobia (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Photophobia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Photopsia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Posterior capsule opacification (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Posterior capsule opacification (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Pterygium (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Punctate keratitis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Refraction disorder (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Refraction disorder (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal haemorrhage (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal haemorrhage (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal pigment epitheliopathy (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal pigment epitheliopathy (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinal tear (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Scleral hyperaemia (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Subretinal fluid (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Trichiasis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ulcerative keratitis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Uveitis (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced transiently (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual acuity reduced transiently (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual brightness (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual brightness (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual impairment (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous detachment (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous detachment (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous disorder (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous floaters (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous floaters (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Fellow Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous haemorrhage (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous opacities (Study Eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Tooth deposit | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Application site pain (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
| |
| Chills | General disorders | MedDRA | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Fibrosis (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site bruising (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site irritation (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site reaction (Study Eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Allergy to arthropod bite | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Allergy to chemicals | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis (Fellow Eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Conjunctivitis (Study Eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Eye infection staphylococcal (Study Eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hordeolum (Fellow Eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Corneal abrasion (Study Eye) | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural complication (Study Eye) | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post procedural discomfort (Study Eye) | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Procedural pain (Study Eye) | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skin injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA | Systematic Assessment |
| |
| Crystal urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Haemoglobin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Fellow Eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Study Eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cell count increased | Investigations | MedDRA | Systematic Assessment |
| |
| Red blood cells urine | Investigations | MedDRA | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA | Systematic Assessment |
| |
| Urine leukocyte esterase positive | Investigations | MedDRA | Systematic Assessment |
| |
| Visual acuity tests abnormal (Study Eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Fracture pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporotic fracture | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Benign neoplasm of eyelid (Fellow Eye) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Eye naevus (Fellow Eye) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Head discomfort | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hyporeflexia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Visual field defect (Fellow Eye) | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Bladder outlet obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatic calcification | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatic haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Prostatomegaly | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tracheomalacia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cutis laxa (Fellow Eye) | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Cutis laxa (Study Eye) | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ecchymosis (Study Eye) | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Precancerous skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Labile hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Poor peripheral circulation | Vascular disorders | MedDRA | Systematic Assessment |
|
Study conducted in 2 parts, Part A (n=150) & Part B (n=8). Total participants is 158
Primary Outcome for Part B is Safety and Tolerability as presented in the Adverse events section of this report
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
Not provided
Not provided
Not provided
| Male |
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| Title | Denominators | Categories |
|---|
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