Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002165-21 | EudraCT Number | ||
| NL62709.000.17 | Other Identifier | Central Committee on Research Involving Human Subjects (CCMO) |
Not provided
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS 416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI activity reduction.
Evaluation of safety, PK, and PD of ISIS 416858 (Dose # 1, Dose #2 and Dose #3 once weekly) as compared to placebo as assessed by FXI activity reduction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
|
| Cohort A: ISIS 416858, 200 mg | Experimental | Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
|
| Cohort B: ISIS 416858, 250 mg | Experimental | Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
|
| Cohort C: ISIS 416858, 300 mg | Experimental | Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISIS 416858 | Drug | Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB) | MB was defined as one of the following: Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular if in a major joint, or pericardial, or intramuscular with compartment syndrome, clinically overt bleeding leading to transfusion of greater than or equal to (>=) 2 units of packed red blood cells or whole blood or a fall in hemoglobin of 20 grams per liter (g/L) (1.24 millimoles per liter [mmol/L]) or more within 24 hours. CRNMB was defined as overt bleeding not meeting the criteria for MB but that resulted, in either medical examination, intervention, or had clinical consequences for a participant. | Up to Day 260 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | Baseline (Day 1) up to Day 260 | |
| Percent Change From Baseline in Factor XI (FXI) Activity | Baseline (Day 1) up to Day 260 | |
Inclusion Criteria:
• End stage renal disease maintained on outpatient hemodialysis at a healthcare center for > 3 months from screening with hemodialysis at least 3 times per week for a minimum of 9 hours per week of prescribed treatment time and plan to continue this throughout the study.
Exclusion Criteria:
Participants with a history of major medical event (previous acute coronary syndrome, stroke or transient ischemic attack or systemic thromboembolic event) within 3 months of screening, major surgery within 3 months of screening, or new major physical examination finding except for documented atrial fibrillation
Active bleeding within the past 3 months from screening or documented bleeding diathesis (excluding uremia), coagulopathy, or recent prolonged compression time at arteriovenous fistula
Screening values of:
Malignancy within 5 years, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. Participants with malignancies that have been treated with curative intent and which have no reoccurrence within 5 years may also be eligible if approved by Sponsor Medical Monitor.
Within 6 months prior to screening, have any of the following:
Planned major surgery in the next 6 months, including participants receiving kidney transplant or participants that anticipate changing dialysis modality (i.e. hemodialysis to peritoneal dialysis)
Concomitant use of anticoagulant/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, clopidogrel) that may affect coagulation (except low dose aspirin (≤ 100 mg/day) during Treatment and Post-treatment Evaluation Periods is not allowed. Stable does of heparins during dialysis are permitted
Uncontrolled hypertension as judged by the Investigator. Participants with a pre- or post-dialysis blood pressure (BP) that is > 180 millimeters of mercury (mmHg) on at least 3 of last 5 dialysis treatments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ionis Investigative Site | Santiago de Compostela | A Coruna | 15706 | Spain | ||
| Ionis Investigative Site |
Not provided
Not provided
Not provided
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A total of 213 participants were enrolled and randomized in the study. Out of 213, 3 participants did not receive the study drug
The study was conducted in 10 countries (Latvia, Netherlands, Spain, Austria, Belgium, Bulgaria, Czech Republic, Greece, Canada, and Russian Federation) from 26 December 2017 to 10 July 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| FG001 | Cohort A: ISIS 416858, 200 mg | Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| FG002 | Cohort B: ISIS 416858, 250 mg | Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| FG003 | Cohort C: ISIS 416858, 300 mg | Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| BG001 | Cohort A: ISIS 416858, 200 mg |
| 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 | Number of Participants With Major Bleeding (MB) and Clinically Relevant Non-Major Bleeding (CRNMB) | MB was defined as one of the following: Fatal bleeding; symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular if in a major joint, or pericardial, or intramuscular with compartment syndrome, clinically overt bleeding leading to transfusion of greater than or equal to (>=) 2 units of packed red blood cells or whole blood or a fall in hemoglobin of 20 grams per liter (g/L) (1.24 millimoles per liter [mmol/L]) or more within 24 hours. CRNMB was defined as overt bleeding not meeting the criteria for MB but that resulted, in either medical examination, intervention, or had clinical consequences for a participant. | Safety population included all randomized participants who received at least 1 dose of the study drug. | Posted | Count of Participants | Participants | Up to Day 260 |
|
Up to Day 260
Safety population included all randomized participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ionis Pharmaceuticals, Inc. | Ionis Pharmaceuticals, Inc. | 800-679-4747 | patients@ionisph.com |
Not provided
| 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 | Jun 14, 2018 | Nov 23, 2022 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C572197 | ISIS 416858 |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Subcutaneous injection |
|
|
| Number of Participants With Laboratory Abnormalities Related to Platelet Count |
Participants were assessed based on pre-defined criteria in the protocol for platelet count abnormality: 100 - less than (<)140, 75 - <100, 50 - <75, 25 - <50 and < 25 thousands per cubic millimeter (K/mm^3) based on investigator's discretion. |
| Up to Day 260 |
| Number of Participants With Laboratory Abnormalities - Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST) | Participants were assessed based on pre-defined criteria in protocol for abnormality in ALT and AST values: Confirmed ALT (serum glutamic pyruvic transaminase [SGPT]); greater than (>) 3*Upper limit of normal range (ULN), >5*ULN and confirmed AST (serum glutamic-oxaloacetic transaminase [SGOT]); >3*ULN and >5*ULN. A confirmed value was based on a consecutive lab value within 7 days of the initial value. If that value was in the same or worse category the initial value was confirmed. If the consecutive value was in a better category then the initial value was confirmed using the consecutive value category. If there were multiple results on the same day, no matter from the same lab vendor or different lab vendors, then the worst value was used in the analysis. Abnormality in laboratory parameter was based on investigator's discretion. | Up to Day 260 |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Up to Day 260 |
| Percent Change From Baseline in Factor XI (FXI) Antigen Levels | Baseline (Day 1) up to Day 260 |
| Alcalá de Henares |
| Madrid |
| 28805 |
| Spain |
| Ineligibility |
|
| Voluntary Withdrawal |
|
| Other |
|
Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period.
| BG002 | Cohort B: ISIS 416858, 250 mg | Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| BG003 | Cohort C: ISIS 416858, 300 mg | Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| OG001 | Cohort A: ISIS 416858, 200 mg | Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| OG002 | Cohort B: ISIS 416858, 250 mg | Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
| OG003 | Cohort C: ISIS 416858, 300 mg | Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. |
|
|
| Other Pre-specified | Percent Change From Baseline in Activated Partial Thromboplastin Time (aPTT) | PP population: All participants, randomized without missing > 2 doses during the first 12 weeks or > 5 doses over the 26-week Treatment Period (TP) and did not have any major protocol violations that would have affected the interpretation/integrity of study results. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) up to Day 260 |
|
|
|
|
| Other Pre-specified | Percent Change From Baseline in Factor XI (FXI) Activity | PP population: All participants, randomized without missing > 2 doses during the first 12 weeks or > 5 doses over the 26-week TP and did not have any major protocol violations that would have affected the interpretation/integrity of study results. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) up to Day 260 |
|
|
|
|
| Other Pre-specified | Number of Participants With Laboratory Abnormalities Related to Platelet Count | Participants were assessed based on pre-defined criteria in the protocol for platelet count abnormality: 100 - less than (<)140, 75 - <100, 50 - <75, 25 - <50 and < 25 thousands per cubic millimeter (K/mm^3) based on investigator's discretion. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Day 260 |
|
|
|
| Other Pre-specified | Number of Participants With Laboratory Abnormalities - Alanine Transaminase (ALT) and Aspartate Aminotransferase (AST) | Participants were assessed based on pre-defined criteria in protocol for abnormality in ALT and AST values: Confirmed ALT (serum glutamic pyruvic transaminase [SGPT]); greater than (>) 3*Upper limit of normal range (ULN), >5*ULN and confirmed AST (serum glutamic-oxaloacetic transaminase [SGOT]); >3*ULN and >5*ULN. A confirmed value was based on a consecutive lab value within 7 days of the initial value. If that value was in the same or worse category the initial value was confirmed. If the consecutive value was in a better category then the initial value was confirmed using the consecutive value category. If there were multiple results on the same day, no matter from the same lab vendor or different lab vendors, then the worst value was used in the analysis. Abnormality in laboratory parameter was based on investigator's discretion. | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Day 260 |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Safety population included all randomized participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to Day 260 |
|
|
|
| Other Pre-specified | Percent Change From Baseline in Factor XI (FXI) Antigen Levels | PP population: All participants, randomized without missing > 2 doses during first 12 weeks or > 5 doses over 26-week TP and did not have any major protocol violations that would have affected interpretation/integrity of study results. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | percentage change | Baseline (Day 1) up to Day 260 |
|
|
|
| 3 |
| 53 |
| 10 |
| 53 |
| 25 |
| 53 |
| EG001 | Cohort A: ISIS 416858, 200 mg | Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. | 0 | 53 | 6 | 53 | 27 | 53 |
| EG002 | Cohort B: ISIS 416858, 250 mg | Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. | 5 | 54 | 20 | 54 | 35 | 54 |
| EG003 | Cohort C: ISIS 416858, 300 mg | Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period. | 1 | 50 | 13 | 50 | 39 | 50 |
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Gastritis erosive | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Sudden death | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Gangrene | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Osteomyelitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arterial bypass thrombosis | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula maturation failure | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Graft thrombosis | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral atrophy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Idiopathic intracranial hypertension | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Dry gangrene | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Extremity necrosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertensive crisis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site discolouration | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Arteriovenous fistula site haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
|
| Percent Change From Baseline at Day 12 |
|
|
| Percent Change From Baseline at Day 15 |
|
|
| Percent Change From Baseline at Day 22 |
|
|
| Percent Change From Baseline at Day 29 |
|
|
| Percent Change From Baseline at Day 36 |
|
|
| Percent Change From Baseline at Day 50 |
|
|
| Percent Change From Baseline at Day 64 |
|
|
| Percent Change From Baseline at Day 78 |
|
|
| Percent Change From Baseline at Day 92 |
|
|
| Percent Change From Baseline at Day 106 |
|
|
| Percent Change From Baseline at Day 120 |
|
|
| Percent Change From Baseline at Day 134 |
|
|
| Percent Change From Baseline at Day 148 |
|
|
| Percent Change From Baseline at Day 162 |
|
|
| Percent Change From Baseline at Day 176 |
|
|
| Percent Change From Baseline at Day 190 |
|
|
| Percent Change From Baseline at Day 204 |
|
|
| Percent Change From Baseline at Day 218 |
|
|
| Percent Change From Baseline at Day 232 |
|
|
| Percent Change From Baseline at Day 246 |
|
|
| Percent Change From Baseline at Day 260 |
|
|
| Other |
|
| Percent Change From Baseline at Day 12 |
|
|
| Percent Change From Baseline at Day 15 |
|
|
| Percent Change From Baseline at Day 22 |
|
|
| Percent Change From Baseline at Day 29 |
|
|
| Percent Change From Baseline at Day 36 |
|
|
| Percent Change From Baseline at Day 50 |
|
|
| Percent Change From Baseline at Day 64 |
|
|
| Percent Change From Baseline at Day 78 |
|
|
| Percent Change From Baseline at Day 92 |
|
|
| Percent Change From Baseline at Day 106 |
|
|
| Percent Change From Baseline at Day 120 |
|
|
| Percent Change From Baseline at Day 134 |
|
|
| Percent Change From Baseline at Day 148 |
|
|
| Percent Change From Baseline at Day 162 |
|
|
| Percent Change From Baseline at Day 176 |
|
|
| Percent Change From Baseline at Day 190 |
|
|
| Percent Change From Baseline at Day 204 |
|
|
| Percent Change From Baseline at Day 218 |
|
|
| Percent Change From Baseline at Day 232 |
|
|
| Percent Change From Baseline at Day 246 |
|
|
| Percent Change From Baseline at Day 260 |
|
|
Wilcoxon Rank Sum Test based on t approximation |
| < 0.05 |
| Other |
| 75 - <100 K/mm^3 |
|
| 50 - <75 K/mm^3 |
|
| 25 - <50 K/mm^3 |
|
| < 25 K/mm^3 |
|
| ALT: >5*ULN, Confirmed |
|
| AST: >3*ULN, Confirmed |
|
| AST: >5*ULN, Confirmed |
|