Not provided
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Not provided
The early termination of this study is a business decision, Akari have made the decision to close their global Phase III PNH program. The decision was not related to any efficacy, safety or clinical concerns regarding Coversin/rVA576.
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Long term management of patients with complement related diseases including Paroxysmal Nocturnal Haemoglobinuria and Atypical Haemolytic Uraemic Syndrome
Patients with diseases requiring complement inhibition who have previously taken part in Akari clinical trials and who wish to continue to receive rVA576 (Coversin) after their active participation in the parent trial has completed and patients treated under compassionate use or named patient arrangements who wish to continue on rVA576 (Coversin) therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rVA576 Coversin | Experimental | The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rVA576 | Drug | The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin). |
| Measure | Description | Time Frame |
|---|---|---|
| Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results. | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | Thrombotic and Haemolytic Events will include, but are not limited to, the following: haemolytic anaemia, thrombocytopenia, red blood cell haemolysis indicated by dark urine, Budd-Chiara syndrome, any other thrombotic or haemolytic event deemed to be associated with PNH. A haemolytic event will be defined as a rise in LDH or other biochemical evidence of haemolysis accompanied by an increase in symptoms and/or frank haemoglobinuria. Increased symptoms without objective haematological or biochemical evidence of haemolysis will not be counted as haemolytic events. In addition, the following signs and symptoms may be reviewed and classified as Thrombotic/Haemolytic events if appropriate: Acute kidney failure, Hypertension, Myocardial infarction, Stroke, Lung complications, Seizure, Coma, Premature death. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wynne Weston Davies | AKARI Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instytut Hematologii i Transfuzjologii | Warsaw | 02-776 | Poland |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | rVA576 Coversin | The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The primary analysis was intention to treat (ITT) and all patients who entered and who signed the ICF were included in the Full Analysis Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | rVA576 Coversin | The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 for up to 4 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Long Term Safety and Efficacy of rVA576 (Coversin) Therapy Assessed by AEs, SAEs, Standard Lab Tests and ECG Results. | To determine the safety profile of long-term rVA576 (Coversin) treatment as assessed by AEs, SAEs, Standard Lab tests and ECG results. | Posted | Count of Participants | Participants | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
|
|
Approximately 3 years and 5 months
Not provided
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 | rVA576 Coversin | The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin) for up to 4 years. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
Due to the early termination of this study, only a subset of the outputs planned were produced. Parent trial locked databases were not pooled with the AK581 database, limiting the scope of the analyses that could be produced. The 'parent trial baseline' could not be used in calculations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Wynne Weston-Davies | Akari Therapeutics Plc | 0208 004 6106 | wynne.weston-davies@akaritx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 11, 2019 | Feb 7, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2019 | Feb 7, 2024 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Open-label, non-comparative
Not provided
Not provided
Not provided
Not provided
|
| On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
| Time to Thrombotic or Haemolytic Event Since Joining This Study. | Time to thrombotic or haemolytic event since joining this study. | Approximately 3 years and 5 months |
| Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
| Time to First Transfusion Since Joining the Study. | Time to first transfusion since joining the study. | approximately 3 years and 5 months |
| Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. | Every 3 months up to 39 months |
| Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | Proportion of subjects with serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. | 12 weeks |
| Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Proportion of subjects with median serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) over the entire duration of the study. | Approximately 3 years and 5 months |
| Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE | Baseline and every 3 months up to 39 months |
| Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE | Approximately 3 years and 5 months |
| Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study. | Approximately 3 years and 5 months |
| Time to First Major Adverse Vascular Event (MAVE) for Each Subject Since Joining the Study. | Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study. | Approximately 3 years and 5 months |
| Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Number of Major Adverse Vascular Events (MAVE) over the entire period of the study. | Approximately 3 years and 5 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Proportion of Subjects With Thrombotic and Haemolytic Event Free Status During Each 3month Time Period Since the Start of the Study. | Thrombotic and Haemolytic Events will include, but are not limited to, the following: haemolytic anaemia, thrombocytopenia, red blood cell haemolysis indicated by dark urine, Budd-Chiara syndrome, any other thrombotic or haemolytic event deemed to be associated with PNH. A haemolytic event will be defined as a rise in LDH or other biochemical evidence of haemolysis accompanied by an increase in symptoms and/or frank haemoglobinuria. Increased symptoms without objective haematological or biochemical evidence of haemolysis will not be counted as haemolytic events. In addition, the following signs and symptoms may be reviewed and classified as Thrombotic/Haemolytic events if appropriate: Acute kidney failure, Hypertension, Myocardial infarction, Stroke, Lung complications, Seizure, Coma, Premature death. | Data are not available for all 15 participants at every 3-month interval due to the early termination of the trial. The proportion of subjects with thrombotic or haemolytic event free status in each 3-month interval is calculated based on the actual number of participants analysed at each 3-month interval. | Posted | Count of Participants | Participants | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
|
|
|
| Secondary | Time to Thrombotic or Haemolytic Event Since Joining This Study. | Time to thrombotic or haemolytic event since joining this study. | Posted | Mean | Standard Deviation | days since first dose | Approximately 3 years and 5 months |
|
|
|
| Secondary | Proportion of Subjects Who Require PRBC Transfusion During Each 3-month Period Since the Start of the Study and Over the Entire Period of the Study | Proportion of subjects who require PRBC transfusion during each 3-month period since the start of the study and over the entire period of the study | Posted | Count of Participants | Participants | On entry and every 3 months thereafter, for the duration of the study (approximately 3 years and 5 months) |
|
|
|
| Secondary | Time to First Transfusion Since Joining the Study. | Time to first transfusion since joining the study. | Posted | Median | Full Range | days | approximately 3 years and 5 months |
|
|
|
| Secondary | Proportion of Subjects With no Adverse Change in Overall Scores of Quality of Life Using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F Instruments at Each 3-month Time Period Since the Start of the Study. | Proportion of subjects with no adverse change in overall scores of Quality of Life using the EORTC QLQ-C30, the EQ-5D-5L and FACIT-F instruments at each 3-month time period since the start of the study. | Not all participants completed the self-reported questionnaires at all timepoints | Posted | Count of Participants | Participants | Every 3 months up to 39 months |
|
|
|
| Secondary | Proportion of Subjects With Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) at Each 3-month Time Period Since the Start of the Study. | Proportion of subjects with serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) at each 3-month time period since the start of the study. | Posted | Number | Participants | 12 weeks |
|
|
|
| Secondary | Proportion of Subjects With Median Serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 Times the Upper Limit of Normal (ULN) Over the Entire Duration of the Study. | Proportion of subjects with median serum Lactate Dehydrogenase (LDH) <1.8, >1.8 to 2.4, >2.4 to 3, and >3 times the upper limit of normal (ULN) over the entire duration of the study. | Posted | Number | Participants | Approximately 3 years and 5 months |
|
|
|
| Secondary | Proportion of Transfusion-independent Subjects at Each 3-month Time Point, With Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Proportion of transfusion-independent subjects at each 3-month time point, with haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE | Total number of subjects analyzed at each timepoint is specified. | Posted | Count of Participants | Participants | Baseline and every 3 months up to 39 months |
|
|
|
| Secondary | Proportion of Transfusion-independent Subjects Over the Entire Duration of the Study With Mean Haemoglobin (g/L) Above the Baseline Haemoglobin Value They Had at the Start of the Trial From Which They Entered CONSERVE | Proportion of transfusion-independent subjects over the entire duration of the study with mean haemoglobin (g/L) above the baseline haemoglobin value they had at the start of the trial from which they entered CONSERVE | Total number of subjects analyzed with post-baseline values is specified. | Posted | Count of Participants | Participants | Approximately 3 years and 5 months |
|
|
|
| Secondary | Proportion of Patients Experiencing Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Proportion of patients experiencing Major Adverse Vascular Events (MAVE) over the entire period of the study. | Posted | Count of Participants | Participants | Approximately 3 years and 5 months |
|
|
|
| Secondary | Time to First Major Adverse Vascular Event (MAVE) for Each Subject Since Joining the Study. | Time to first Major Adverse Vascular Event (MAVE) for each subject since joining the study. | There were no Major Adverse Vascular Events (MAVEs) reported during the entire period of the study. | Posted | Approximately 3 years and 5 months |
|
|
| Secondary | Number of Major Adverse Vascular Events (MAVE) Over the Entire Period of the Study. | Number of Major Adverse Vascular Events (MAVE) over the entire period of the study. | Posted | Number | events | Approximately 3 years and 5 months |
|
|
|
| 0 |
| 15 |
| 3 |
| 15 |
| 14 |
| 15 |
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Toxicity to various agents | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Intravascular haemolysis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Bronchitis | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
|
| Paroxysmal nocturnal haemoglobinuria | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
| Haemoglobinuria | Renal and urinary disorders | Systematic Assessment |
|
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Calculus urinary | Renal and urinary disorders | Systematic Assessment |
|
| Renal colic | Renal and urinary disorders | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Influenza like illness | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Fatigue | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Injection site pain | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Injection site pruritus | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Injection site swelling | General disorders | Systematic Assessment | System Organ Class: General disorders & administration site conditions |
|
| Urinary casts | Investigations | Systematic Assessment |
|
| White blood cells urine positive | Investigations | Systematic Assessment |
|
| Blood LDH increased | Investigations | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | Systematic Assessment |
|
| WBC decreased | Investigations | Systematic Assessment |
|
| Glucose urine present | Investigations | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | Systematic Assessment |
|
| Liver function test abnormal | Investigations | Systematic Assessment |
|
Not provided
Not provided
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
|
| Proportion of subjects with thrombotic event free status: >6 - 9 Months |
|
|
| Proportion of subjects with thrombotic event free status: >9 - 12 Months |
|
|
| Proportion of subjects with thrombotic event free status: >12 - 15 Months |
|
|
| Proportion of subjects with thrombotic event free status: >15 - 18 Months |
|
|
| Proportion of subjects with thrombotic event free status: >18 - 21 Months |
|
|
| Proportion of subjects with thrombotic event free status: >21 - 24 Months |
|
|
| Proportion of subjects with thrombotic event free status: >24 - 27 Months |
|
|
| Proportion of subjects with thrombotic event free status: >27 - 30 Months |
|
|
| Proportion of subjects with thrombotic event free status: >30 Months |
|
|
| Proportion of subjects with haemolytic event free status: 0 - 3 Months |
|
|
| Proportion of subjects with haemolytic event free status: >3 - 6 Months |
|
|
| Proportion of subjects with haemolytic event free status: >6 - 9 Months |
|
|
| Proportion of subjects with haemolytic event free status: >9 - 12 Months |
|
|
| Proportion of subjects with haemolytic event free status: >12 - 15 Months |
|
|
| Proportion of subjects with haemolytic event free status: >15 - 18 Months |
|
|
| Proportion of subjects with haemolytic event free status: >18 - 21 Months |
|
|
| Proportion of subjects with haemolytic event free status: >21 - 24 Months |
|
|
| Proportion of subjects with haemolytic event free status: >24 - 27 Months |
|
|
| Proportion of subjects with haemolytic event free status: >27 - 30 Months |
|
|
| Proportion of subjects with haemolytic event free status: >30 Months |
|
|
| Title | Measurements |
|---|---|
|
| >9 - 12 Months |
|
| >12 - 15 Months |
|
| >15 - 18 Months |
|
| >18 - 21 Months |
|
| >21 - 24 Months |
|
| >24 - 27 Months |
|
| >27 - 30 Months |
|
| >30 Months |
|
| Entire Study |
|
|
| >6 - 9 Months - EORTC QLQ-C30 |
|
|
| >9 - 12 Months - EORTC QLQ-C30 |
|
|
| >12 - 15 Months - EORTC QLQ-C30 |
|
|
| >15 - 18 Months - EORTC QLQ-C30 |
|
|
| >18 - 21 Months - EORTC QLQ-C30 |
|
|
| >21 - 24 Months - EORTC QLQ-C30 |
|
|
| >24 - 27 Months - EORTC QLQ-C30 |
|
|
| >27 - 30 Months - EORTC QLQ-C30 |
|
|
| >30 - 33 Months - EORTC QLQ-C30 |
|
|
| >33 - 36 Months - EORTC QLQ-C30 |
|
|
| >36 - 39 Months - EORTC QLQ-C30 |
|
|
| 0 - 3 Months - EQ-5D-5L |
|
|
| >3 - 6 Months - EQ-5D-5L |
|
|
| >6 - 9 Months - EQ-5D-5L |
|
|
| >9 - 12 Months - EQ-5D-5L |
|
|
| >12 - 15 Months - EQ-5D-5L |
|
|
| >15 - 18 Months - EQ-5D-5L |
|
|
| >18 - 21 Months - EQ-5D-5L |
|
|
| >21 - 24 Months - EQ-5D-5L |
|
|
| >24 - 27 Months - EQ-5D-5L |
|
|
| >27 - 30 Months - EQ-5D-5L |
|
|
| >30 - 33 Months - EQ-5D-5L |
|
|
| >33 - 36 Months - EQ-5D-5L |
|
|
| >36 - 39 Months - EQ-5D-5L |
|
|
| 0 - 3 Months - FACIT-F |
|
|
| >3 - 6 Months - FACIT-F |
|
|
| >6 - 9 Months - FACIT-F |
|
|
| >9 - 12 Months - FACIT-F |
|
|
| >12 - 15 Months - FACIT-F |
|
|
| >15 - 18 Months - FACIT-F |
|
|
| >18 - 21 Months - FACIT-F |
|
|
| >21 - 24 Months - FACIT-F |
|
|
| >24 - 27 Months - FACIT-F |
|
|
| >27 - 30 Months - FACIT-F |
|
|
| >30 - 33 Months - FACIT-F |
|
|
| >33 - 36 Months - FACIT-F |
|
|
| >36 - 39 Months - FACIT-F |
|
|
|
| Month 6 |
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Month 15 |
|
|
| Month 18 |
|
|
| Month 21 |
|
|
| Month 24 |
|
|
| Month 27 |
|
|
| Month 30 |
|
|
| Month 33 |
|
|
| Month 36 |
|
|
| Month 39 |
|
|
|