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| Name | Class |
|---|---|
| Eidos Therapeutics, a BridgeBio company | INDUSTRY |
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This prospective study is designed to evaluate the efficacy, safety, and tolerability of ALXN2060 (also known as AG10), as well as to establish its pharmacokinetic and pharmacodynamic profile in Japanese participants with symptomatic ATTR-CM administered on a background of stable heart failure therapy.
Participants will receive ALXN2060 for 12 months (Part A). Following the last visit (Month 12) of Part A, participants will continue the study in Part B, which will last for an additional 18 months (30 months from Day 1), during which all participants will continue to receive oral treatment with ALXN2060. Following completion of Month 30 assessments in Part B, participants will be offered the opportunity to continue to receive ALXN2060 in the Extension Period, which will last until ALXN2060 is approved in Japan or for up to 24 additional months, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN2060 | Experimental | Participants will receive ALXN2060. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN2060 | Drug | ALXN2060 tablets will be administered twice daily at a dose of 800 milligrams. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change From Baseline To Month 12 Of Treatment In Distance Walked During The Six-minute Walk Test (6MWT) | The 6MWT measures how far a participant can walk in 6 minutes. Change from baseline was calculated as the difference between the distance walked during the 6MWT at 12 months and the distance walked during the 6MWT at baseline. To determine the baseline, at least 2 6MWTs were conducted > 24 hours to ≤ 3 weeks apart prior to the first dose of ALXN2060. The baseline 6MWT is the average of the total distance walked by participants for the 2 qualifying 6MWTs that met all the protocol-defined criteria. Least squares mean change from baseline data were adjusted for baseline measures and visits. | Baseline, Month 12 |
| Parts A and B: Number of Cardiovascular (CV)-Related Hospitalizations Over A 30-month Period | CV-related hospitalization was defined as the mean number of CV-related hospitalizations per participant per year over a 30-month period. CV-related hospitalizations were also reported as adverse events and were reviewed and adjudicated by an independent Clinical Events Committee (CEC). | 30 months |
| All-cause Mortality (ACM) Over A 30-month Period | ACM was assessed as time from the date of first initiation of study treatment to the date of death during a 30-month period, and was analyzed using Kaplan-Meier analysis. Data are reported for the number of participants with ACM over the 30-month period. | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Change From Baseline In Distance Walked During The 6MWT | The 6MWT measures how far a participant can walk in 6 minutes. Change from baseline was calculated as the difference between the distance walked during the 6MWT at specified timepoints and the distance walked during the 6MWT at baseline. To determine the baseline, at least 2 6MWTs were conducted > 24 hours to ≤ 3 weeks apart prior to the first dose of ALXN2060. The baseline 6MWT is the average of the total distance walked by participants for the 2 qualifying 6MWTs that met all the protocol-defined criteria. Least squares mean change from baseline data were adjusted for baseline measures and visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bunkyō City | 113-8431 | Japan | |||
| Research Site |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ALXN2060 | Participants received ALXN2060 twice daily (bid) for 12 months (Part A). Following the Month 12 visit, participants continued to receive ALXN2060 bid for an additional 18 months (up to 30 months from Day 1, [Part B]). Following the completion of Month 30 assessments in Part B, participants were offered the opportunity to continue into the Extension Period for up to 30 additional months or until ALXN2060 could be provided via an Alexion post-study access program (as allowed by local laws and regulations) or until the start of commercial drug use if the marketing approval of investigational product is obtained in Japan, whichever occurred first. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period (Part A + Part B) |
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| ||||||||||||||||||||||||
| Extension Period |
|
Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALXN2060 | Participants received ALXN2060 bid for 12 months (Part A). Following the Month 12 visit, participants continued to receive ALXN2060 bid for an additional 18 months (up to 30 months from Day 1, [Part B]). Following the completion of Month 30 assessments in Part B, participants were offered the opportunity to continue into the Extension Period for up to 30 additional months or until ALXN2060 could be provided via an Alexion post-study access program (as allowed by local laws and regulations) or until the start of commercial drug use if the marketing approval of investigational product is obtained in Japan, whichever occurred first. |
| 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 | Part A: Change From Baseline To Month 12 Of Treatment In Distance Walked During The Six-minute Walk Test (6MWT) | The 6MWT measures how far a participant can walk in 6 minutes. Change from baseline was calculated as the difference between the distance walked during the 6MWT at 12 months and the distance walked during the 6MWT at baseline. To determine the baseline, at least 2 6MWTs were conducted > 24 hours to ≤ 3 weeks apart prior to the first dose of ALXN2060. The baseline 6MWT is the average of the total distance walked by participants for the 2 qualifying 6MWTs that met all the protocol-defined criteria. Least squares mean change from baseline data were adjusted for baseline measures and visits. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. Number of participants analyzed = number of participants evaluable for the outcome measure at the specified timepoint. | Posted | Least Squares Mean | Standard Error | meters | Baseline, Month 12 |
|
Up to approximately Month 57
All-cause mortality is reported for all enrolled participants. Serious and other adverse events are reported for the overall study based upon the Long-term Safety and Efficacy analysis set which included all participants who received at least 1 dose of ALXN2060.
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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 | ALXN2060 | Participants received ALXN2060 bid for 12 months (Part A). Following the Month 12 visit, participants continued to receive ALXN2060 bid for an additional 18 months (up to 30 months from Day 1, [Part B]). Following the completion of Month 30 assessments in Part B, participants were offered the opportunity to continue into the Extension Period for up to 30 additional months or until ALXN2060 could be provided via an Alexion post-study access program (as allowed by local laws and regulations) or until the start of commercial drug use if the marketing approval of investigational product is obtained in Japan, whichever occurred first. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | 855-752-2356 | clinicaltrials@alexion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 11, 2023 | Oct 24, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 27, 2023 | Oct 24, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000731204 | attruby |
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| Baseline, Months 6, 9, 18, 24 and 30 |
| Parts A and B: Change From Baseline In The Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) | The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in participants with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life. The overall summary score ranged from 0-100, with higher scores indicating better health status. Data presented are for change from baseline to specified timepoints. Least squares mean change from baseline data were adjusted for baseline measures and visits. | Baseline, Months 6, 9, 12, 18, 24 and 30 |
| Parts A and B: Number of Participants With Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation | A treatment-emergent AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention that occurred after first dose. A treatment-emergent SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect that occurred after first dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Up to Month 30 |
| Parts A and B: Change From Baseline In Serum Transthyretin (TTR) Concentration | Least squares mean change from baseline derived from with visits and baseline serum TTR as a covariate. Other covariates were included as needed. | Baseline, pre-dose on Days 14, 28 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 |
| Parts A and B: Change From Baseline In TTR Stabilization | TTR stabilization was measured using fluorescent probe exclusion (FPE). Data presented are for change from baseline in FPE percentage stabilization. | Baseline, Pre-dose Days 14, 28 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 |
| Fukuoka |
| 812-8582 |
| Japan |
| Research Site | Kumamoto | 860-8556 | Japan |
| Research Site | Kurume-shi | 830-0011 | Japan |
| Research Site | Matsumoto-shi | 390-8621 | Japan |
| Research Site | Nagoya | 466-8560 | Japan |
| Research Site | Nankoku-shi | 783-8505 | Japan |
| Research Site | Sagamihara-shi | 252-0375 | Japan |
| Research Site | Sapporo | 060-8543 | Japan |
| Research Site | Shinjuku-ku | 160-8582 | Japan |
| Research Site | Suita-shi | 564-8565 | Japan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ALXN2060 |
Participants received ALXN2060 bid for 12 months (Part A). Following the Month 12 visit, participants continued to receive ALXN2060 bid for an additional 18 months (up to 30 months from Day 1, [Part B]). Following the completion of Month 30 assessments in Part B, participants were offered the opportunity to continue into the Extension Period for up to 30 additional months or until ALXN2060 could be provided via an Alexion post-study access program (as allowed by local laws and regulations) or until the start of commercial drug use if the marketing approval of investigational product is obtained in Japan, whichever occurred first. |
|
|
| Primary | Parts A and B: Number of Cardiovascular (CV)-Related Hospitalizations Over A 30-month Period | CV-related hospitalization was defined as the mean number of CV-related hospitalizations per participant per year over a 30-month period. CV-related hospitalizations were also reported as adverse events and were reviewed and adjudicated by an independent Clinical Events Committee (CEC). | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. | Posted | Mean | 95% Confidence Interval | CV-related hospitalizations | 30 months |
|
|
|
| Secondary | Parts A and B: Change From Baseline In Distance Walked During The 6MWT | The 6MWT measures how far a participant can walk in 6 minutes. Change from baseline was calculated as the difference between the distance walked during the 6MWT at specified timepoints and the distance walked during the 6MWT at baseline. To determine the baseline, at least 2 6MWTs were conducted > 24 hours to ≤ 3 weeks apart prior to the first dose of ALXN2060. The baseline 6MWT is the average of the total distance walked by participants for the 2 qualifying 6MWTs that met all the protocol-defined criteria. Least squares mean change from baseline data were adjusted for baseline measures and visits. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. "Number analyzed" = participants evaluable for this outcome measure at the specified timepoint. | Posted | Least Squares Mean | Standard Error | meters | Baseline, Months 6, 9, 18, 24 and 30 |
|
|
|
| Secondary | Parts A and B: Change From Baseline In The Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS) | The KCCQ is a 23-item questionnaire developed to measure health status and health-related quality of life in participants with heart failure. Items include heart failure symptoms, impact on physical and social functions, and how their heart failure impacts their quality of life. The overall summary score ranged from 0-100, with higher scores indicating better health status. Data presented are for change from baseline to specified timepoints. Least squares mean change from baseline data were adjusted for baseline measures and visits. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. "Number analyzed" = participants evaluable for this outcome measure at the specified timepoint. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline, Months 6, 9, 12, 18, 24 and 30 |
|
|
|
| Secondary | Parts A and B: Number of Participants With Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Treatment Discontinuation | A treatment-emergent AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention that occurred after first dose. A treatment-emergent SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or was a congenital anomaly/birth defect that occurred after first dose. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | Measured in the Safety Set, which included all participants who have received at least 1 dose of ALXN2060. | Posted | Count of Participants | Participants | Up to Month 30 |
|
|
|
| Secondary | Parts A and B: Change From Baseline In Serum Transthyretin (TTR) Concentration | Least squares mean change from baseline derived from with visits and baseline serum TTR as a covariate. Other covariates were included as needed. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. "Number analyzed" = participants evaluable for this outcome measure at the specified timepoint. | Posted | Least Squares Mean | Standard Error | milligrams (mg)/deciliter (dL) | Baseline, pre-dose on Days 14, 28 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 |
|
|
|
| Secondary | Parts A and B: Change From Baseline In TTR Stabilization | TTR stabilization was measured using fluorescent probe exclusion (FPE). Data presented are for change from baseline in FPE percentage stabilization. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. "Number analyzed" = participants evaluable for this outcome measure at the specified timepoint. | Posted | Median | Inter-Quartile Range | percentage stabilization | Baseline, Pre-dose Days 14, 28 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27 and 30 |
|
|
|
| Primary | All-cause Mortality (ACM) Over A 30-month Period | ACM was assessed as time from the date of first initiation of study treatment to the date of death during a 30-month period, and was analyzed using Kaplan-Meier analysis. Data are reported for the number of participants with ACM over the 30-month period. | Measured in the Full Analysis Set, which included all participants who have received at least 1 dose of ALXN2060. | Posted | Count of Participants | Participants | 30 months |
|
|
|
| 1 |
| 25 |
| 17 |
| 25 |
| 25 |
| 25 |
| Atrioventricular block complete | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Cardiac discomfort | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Sinus arrest | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Appendicitis perforated | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Bacterial prostatitis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Blood creatine phosphokinase MB increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Soft tissue mass | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
|
| Device dislocation | Product Issues | MedDRA version 28.0 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
|
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
|
| Laryngeal injury | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Adult T-cell lymphoma/leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 28.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Embolic stroke | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA version 28.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA version 28.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 28.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 28.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA version 28.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA version 28.0 | Systematic Assessment | This adverse event is gender specific. So, the number of participants at risk is male population only. |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Atrial tachycardia | Cardiac disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA version 28.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 28.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA version 28.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA version 28.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 28.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 28.0 | Systematic Assessment |
|
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| Month 18 |
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| Month 24 |
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| Month 30 |
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| Month 12 |
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| Month 18 |
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| Month 24 |
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| Month 30 |
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| Title | Measurements |
|---|---|
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| Month 3, Predose |
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| Month 6, Predose |
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| Month 9, Predose |
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| Month 12, Predose |
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| Month 15, Predose |
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| Month 18, Predose |
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| Month 21, Predose |
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| Month 24, Predose |
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| Month 27, Predose |
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| Month 30, Predose |
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| Month 3, Predose |
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| Month 6, Predose |
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| Month 9, Predose |
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| Month 12, Predose |
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| Month 15, Predose |
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| Month 18, Predose |
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| Month 21, Predose |
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| Month 24, Predose |
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| Month 27, Predose |
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| Month 30, Predose |
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