Aplastic Anemia
Conditions
Keywords
Aplastic anemia, deferasirox, ICL670, renal function, transfusion-dependent iron overload, immunosuppressive treatment, Cyclosporine A, unosuppressive treatment without chelation therapy
Brief summary
Evaluated Exjade efficacy and safety in patients with aplastic anemia and transfusion-dependent iron overload, undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) , in comparison with a group of patients undergoing treatment programs of immunosuppressive treatment (Cyclosporine A) without chelation therapy.
Detailed description
The secondary endpoints that were originally planned for this study were not analyzed as the study ended prematurely.
Interventions
DRUGICL670
ICL670 was supplied in registered packages as 250mg or 500mg dispersible tablets.
DRUGChelation
Main group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment (immunosupressant - Cyclosporine A) and received chelation with ICL670 (deferasirox).
DRUGNo chelation
Comparative group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment ( immunosupressant -Cyclosporine A)
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Main diagnosis: aplastic anemia * Absence of severe and/or uncontrolled comorbidities * Confirmed iron overload (serum ferritin ≥ 1000 mkg/L) * Serum creatinine is not higher than the upper limit of normal for the given age * Absence of severe proteinuria. Protein/Creatinine ratio should be \< 0.5 mg/mg * Liver enzymes are \< 5 ULN * Completion of a scheduled cycle of immunosuppressive treatment program, with no severe infectious or generalized hemorrhagic complications * WHO (ECOG) performance status ≤ 2
Exclusion criteria
* No signed informed consent form * Patient is under 18 years old * Severe concomitant condition * Severe infectious and generalized haemorrhagic complication following regular planned cycle of programmed immune suppressive treatment. * History of increased sensitivity to active substance and any other ingredient of the medicinal product. * Creatinine clearance (CC) \< 60 ml/min and/or creatinine concentration in blood serum is 2 or more times higher than upper limit of age normal by results of 2 tests at Visits 1 and 2. * Severe liver disorders (class C by Child-Pugh scale). * Patients with aplastic anaemia in which chelator treatment will be ineffective due to rapid progression of the disease. * Significant proteinuria basing on protein creatinine ratio \> 1.0 mg/ml in urine sample from second urination at Visits 1 and 2 (or as an alternative in 2 of 3 urine samples at screening); * Rare hereditary disorders related to galactose intolerance, severe deficit of lactase or glucose-galactose malabsorption; * Pregnancy, lactation; * Level of liver enzymes higher than 5 upper limits of age normal at Visits 1 and 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum Ferritin Values | Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52 | Change from baseline was be summarized descriptively for all on-treatment study visits. Changes to the planned statistical analysis were related to significant withdrawal of patients from the Per-Protocol Analysis Set due to a large number of patients who discontinued the study (lack of assessments of iron exchange parameters at visits) and deviations from the Protocol affecting the assessment of efficacy parameters. Because of that, the additional efficacy analysis in the Per-Protocol Analysis Set was not performed. |
| Change in Transferrin Saturation With Iron (TSI) Values | Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52 | Mean percentage change from baseline in transferrin saturation with iron was summarized descriptively for all on-treatment study visits. |
| Change in Serum Total Iron-binding Capacity (TIBC) | Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52 | Mean change from baseline in serum total iron-binding capacity was summarized descriptively for all on-treatment study visits. |
Countries
Russia
Participant flow
Recruitment details
Estimated number of patients was 25; the actual number of patients enrolled in the study and included in efficacy analysis was 15.
Pre-assignment details
The study enrolled adult transfusion-dependent patients with Aplastic Anaemia (AA) on programmed immune suppressive treatment.
Participants by arm
| Arm | Count |
|---|---|
| Serum Ferritin Level ≥ 1,000 μg/l Transfusion-dependent adult patients with AA and serum ferritin ≥ 1000 mg/L on programmed immune suppressive treatment with cyclosporine A who were receiving chelation with Exjade (deferasirox) during the study | 10 |
| Serum Ferritin Level < 1,000 μg/l Transfusion-dependent adult patients with AA and serum ferritin \< 1,000 mg/L on programmed immune suppressive treatment with cyclosporine A who were not receiving the investigational product | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative reasons | 5 | 1 |
| Overall Study | Decision to perform 2nd course of trtmnt | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Serum Ferritin Level ≥ 1,000 μg/l | Serum Ferritin Level < 1,000 μg/l | Total |
|---|---|---|---|
| Age, Continuous | 34.0 Years STANDARD_DEVIATION 9.33 | 37.0 Years STANDARD_DEVIATION 10.1 | 35.0 Years STANDARD_DEVIATION 9.34 |
| Race/Ethnicity, Customized Caucasian | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 4 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
Primary
Change in Serum Ferritin Values
Change from baseline was be summarized descriptively for all on-treatment study visits. Changes to the planned statistical analysis were related to significant withdrawal of patients from the Per-Protocol Analysis Set due to a large number of patients who discontinued the study (lack of assessments of iron exchange parameters at visits) and deviations from the Protocol affecting the assessment of efficacy parameters. Because of that, the additional efficacy analysis in the Per-Protocol Analysis Set was not performed.
Time frame: Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52
Population: Full Analysis Set included all patients of the Safety Analysis Set with available baseline data \& data obtained at follow-up visits \&/or final visit, for evaluation of at least 1 efficacy parameter. Statistical analysis was not performed due to large number of patients discontinuing \& thus lack of assessments of iron exchange parameters at visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 4 | 2089.62 ng/ml | Standard Deviation 638.29 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 20 | 2054.23 ng/ml | Standard Deviation 729.14 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 52 | 1288.80 ng/ml | — |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 24 | 1710.67 ng/ml | Standard Deviation 653.13 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 8 | 2498.58 ng/ml | Standard Deviation 1165.94 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 28 | 1446.07 ng/ml | Standard Deviation 395.17 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 0 | 2895.62 ng/ml | Standard Deviation 1245.81 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 32 | 1626.28 ng/ml | Standard Deviation 689.86 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 12 | 2262.12 ng/ml | Standard Deviation 916.65 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 36 | 1709.07 ng/ml | Standard Deviation 1153.94 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Screening | 2866.14 ng/ml | Standard Deviation 1460.13 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 40 | 1897.05 ng/ml | Standard Deviation 1107.95 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 16 | 2164.01 ng/ml | Standard Deviation 886.93 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 44 | 1301.80 ng/ml | Standard Deviation 460.31 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Ferritin Values | Week 48 | 1740.00 ng/ml | Standard Deviation 1493.24 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 44 | 661.13 ng/ml | Standard Deviation 267.15 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 48 | 709.50 ng/ml | Standard Deviation 305.32 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 52 | 655.07 ng/ml | Standard Deviation 277.98 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Screening | 769.02 ng/ml | Standard Deviation 230.36 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 0 | 727.68 ng/ml | Standard Deviation 299.61 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 4 | 640.75 ng/ml | Standard Deviation 292.14 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 8 | 623.14 ng/ml | Standard Deviation 223.27 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 12 | 653.62 ng/ml | Standard Deviation 311.72 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 16 | 647.58 ng/ml | Standard Deviation 225.28 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 20 | 646.80 ng/ml | Standard Deviation 147.73 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 24 | 680.08 ng/ml | Standard Deviation 182.24 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 28 | 526.17 ng/ml | Standard Deviation 122.4 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 32 | 687.37 ng/ml | Standard Deviation 114.47 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 36 | 699.13 ng/ml | Standard Deviation 217.38 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Ferritin Values | Week 40 | 717.33 ng/ml | Standard Deviation 306.63 |
Primary
Change in Serum Total Iron-binding Capacity (TIBC)
Mean change from baseline in serum total iron-binding capacity was summarized descriptively for all on-treatment study visits.
Time frame: Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52
Population: Full Analysis Set (FAS) included all patients of the Safety Analysis Set with the available baseline data, as well as data obtained at follow-up visits and/or the final visit, for evaluation of at least one efficacy parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 12 | 83.56 μmol/l | Standard Deviation 19.86 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 28 | 101.90 μmol/l | Standard Deviation 23.71 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 0 | 49.98 μmol/l | Standard Deviation 10.17 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 32 | 72.85 μmol/l | Standard Deviation 25.92 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 16 | 85.31 μmol/l | Standard Deviation 23.12 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 36 | 76.56 μmol/l | Standard Deviation 19.13 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 8 | 73.90 μmol/l | Standard Deviation 10.97 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 40 | 83.50 μmol/l | Standard Deviation 19.74 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 20 | 74.34 μmol/l | Standard Deviation 18.95 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 44 | 71.56 μmol/l | Standard Deviation 23.95 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 4 | 78.70 μmol/l | Standard Deviation 20.93 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 48 | 74.30 μmol/l | Standard Deviation 11.61 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 24 | 81.90 μmol/l | Standard Deviation 27.17 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 52 | 67.10 μmol/l | Standard Deviation 26.87 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Screening | 4.51 μmol/l | Standard Deviation 9.34 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 52 | 46.77 μmol/l | Standard Deviation 5.39 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Screening | 66.68 μmol/l | Standard Deviation 14.95 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 0 | 49.10 μmol/l | Standard Deviation 5.73 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 4 | 49.00 μmol/l | Standard Deviation 4.95 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 8 | 47.44 μmol/l | Standard Deviation 5.09 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 12 | 47.20 μmol/l | Standard Deviation 4.68 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 16 | 49.53 μmol/l | Standard Deviation 8.03 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 20 | 48.63 μmol/l | Standard Deviation 4.46 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 24 | 46.53 μmol/l | Standard Deviation 5.82 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 28 | 45.97 μmol/l | Standard Deviation 4.14 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 32 | 48.23 μmol/l | Standard Deviation 2.05 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 36 | 47.53 μmol/l | Standard Deviation 2.6 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 40 | 46.30 μmol/l | Standard Deviation 4.49 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 44 | 44.10 μmol/l | Standard Deviation 4.22 |
| Serum Ferritin Level < 1,000 μg/l | Change in Serum Total Iron-binding Capacity (TIBC) | Week 48 | 45.70 μmol/l | Standard Deviation 5.57 |
Primary
Change in Transferrin Saturation With Iron (TSI) Values
Mean percentage change from baseline in transferrin saturation with iron was summarized descriptively for all on-treatment study visits.
Time frame: Screening, Week (Wk) 4, Wk 8, Wk 12, Wk 16, Wk 20, Wk 24, Wk 28, Wk 32, Wk 36, Wk 40, Wk 44, Wk 48, Wk 52
Population: Full Analysis Set (FAS) included all patients of the Safety Analysis Set with the available baseline data, as well as data obtained at follow-up visits and/or the final visit, for evaluation of at least one efficacy parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Screening | 88.80 Percentage of saturation | Standard Deviation 10.01 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 0 | 87.19 Percentage of saturation | Standard Deviation 10.49 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 4 | 73.37 Percentage of saturation | Standard Deviation 8.55 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 8 | 72.68 Percentage of saturation | Standard Deviation 9.49 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 12 | 72.43 Percentage of saturation | Standard Deviation 5.98 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 16 | 68.60 Percentage of saturation | Standard Deviation 9.21 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 20 | 68.14 Percentage of saturation | Standard Deviation 19.64 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 24 | 74.30 Percentage of saturation | Standard Deviation 11.79 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 28 | 65.05 Percentage of saturation | Standard Deviation 7.57 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 32 | 75.75 Percentage of saturation | Standard Deviation 12.98 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 36 | 65.94 Percentage of saturation | Standard Deviation 13.87 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 40 | 66.05 Percentage of saturation | Standard Deviation 9.51 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 44 | 69.22 Percentage of saturation | Standard Deviation 16.95 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 48 | 71.07 Percentage of saturation | Standard Deviation 12.87 |
| Serum Ferritin Level ≥ 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 52 | 83.40 Percentage of saturation | Standard Deviation 11.74 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 52 | 43.57 Percentage of saturation | Standard Deviation 4.09 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Screening | 53.70 Percentage of saturation | Standard Deviation 10.28 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 40 | 43.07 Percentage of saturation | Standard Deviation 2.57 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 0 | 54.88 Percentage of saturation | Standard Deviation 14.5 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 28 | 52.67 Percentage of saturation | Standard Deviation 12.49 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 4 | 50.10 Percentage of saturation | Standard Deviation 14.14 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 48 | 44.20 Percentage of saturation | Standard Deviation 1.39 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 8 | 49.54 Percentage of saturation | Standard Deviation 17.12 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 32 | 49.90 Percentage of saturation | Standard Deviation 11.96 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 12 | 49.04 Percentage of saturation | Standard Deviation 10.15 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 44 | 33.27 Percentage of saturation | Standard Deviation 9.63 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 16 | 52.78 Percentage of saturation | Standard Deviation 9.21 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 36 | 47.83 Percentage of saturation | Standard Deviation 4.91 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 20 | 50.65 Percentage of saturation | Standard Deviation 11.45 |
| Serum Ferritin Level < 1,000 μg/l | Change in Transferrin Saturation With Iron (TSI) Values | Week 24 | 5.90 Percentage of saturation | Standard Deviation 5.59 |