Thalassemia, Non-transfusional-dependent Thalassemia (NTDT), Myeloplastic Dysplasia (MDS), Other Anemia
Conditions
Keywords
iron overload, liver iron concentration (LIC), cardiac siderosis, transfusional siderosis, magnetic resonance imaging (MRI)
Brief summary
Iron, one of the most common elements in nature and the most abundant transition metal in the body, is readily capable of accepting and donating electrons. This capability makes iron a useful component of various, essential biochemical processes. Despite the essential role of iron, the excess of iron is toxic to the human body. It is critical for the human body to maintain iron balance, since humans have no physiologic mechanism for actively removing iron from the body. The development of iron overload occurs when iron intake exceeds the body's capacity to safely store the iron in the liver, which is the primary store for iron. Long-term transfusion therapy, a life-giving treatment for patients with intractable chronic anemia is currently the most frequent cause of secondary iron overload. The mounting evidence regarding the mortality and morbidity due to chronic iron overload in transfusion dependent anaemias has led to the establishment of guidelines that aim the improvement of patient outcomes. Further prospective studies are warranted in order to assess the impact of iron overload in patients with acquired anaemias. In this study, non-invasive R2- and T2\*-MRI techniques were applied to the liver and the heart, respectively, to complement the primary variable (serum ferritin) assessed in patients with various transfusion-dependent anaemias. The main objective of this study was to assess the prevalence and severity of cardiac and liver siderosis in patients with transfusional siderosis. This study was also aim to establish possible correlations between cardiac and liver iron levels with clinical effects in patients with different transfusion-dependent anaemias. Patients were eligible for enrollment irrespective of receiving chelation therapy or not (and irrespective of the chelating agent used).
Detailed description
This study was designed to collect information about a large cohort of patients with anaemias including MDS, aplastic anemia, Diamond-Blackfan, myeloproliferative disorder, as well as haemoglobinopathies (e.g. thalassaemia major, SCD) or other anaemias requiring chronic red blood cell transfusions. Clinical data was collected retrospectively (if available), unless specified by this protocol (e.g. serum ferritin within less than one month prior to enrollment). All assessments required for this protocol were performed after the patient informed consent is signed. The data was gathered by all study centers and was combined in one central database. Data was recorded using an electronic case report form (eCRF) at each study site. Adverse events and serious adverse events were recorded for all patients from the date of signed patient informed consent until the MRI tests are performed.
Interventions
DEVICEMRI scan
MRI was used to measure both liver and cardiac iron loading (R2 by FerriScan and T2\*, respectively).
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Confirmed clinical diagnosis of one of the following disease states: 1. Myelodysplastic syndromes, 2. Thalassaemia major, 3.Other anaemias (e.g. NTDT, SCD, Diamond-Blackfan anaemia, aplastic anaemia, myeloproliferative disease) * Lifetime history of at least 20 units of red blood cell transfusions AND serum ferritin level \> 500 ng/ml; patients with NTDT are not required to have a minimum of 20 units of red blood cell transfusions, but must have serum ferritin level \> 300 ng/ml (serum ferritin for all patients must be measured up to 1 month prior to enrollment) * Written informed consent obtained prior to any procedure required by this protocol
Exclusion criteria
Any condition that does not allow the MRI test to be performed: 1. Cardiac pacemaker, 2. Ferromagnetic metal implants other than those approved as safe for use in MR scanners (Example: some types of aneurysm clips, shrapnel), 3. Obesity (exceeding the equipment limits), 4. Patients who are claustrophobic to MR Women who are pregnant Unwillingness or being unable to give consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Cardiac and Liver Iron Overload. | 2 months | Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2\*, respectively). |
| Cardiac Siderosis Severity | 2 months | Cardiac siderosis severity was measured by MRI (T2\*). The severity grade of siderosis was tiered in 3 levels: mild (T2\* \>= 20ms), moderate (T2\* from 10 to 20ms), and severe (T2\* \<10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events | 12 months - retrospective | Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups. |
| Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events | 12 months - retrospective | Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups. |
| Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events | 12 months - retrospective | Mean cardiac T2\* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data. |
| Mean LIC According to the Presence or Absence of Retrospective Hepatic Events | 12 months - retrospective | Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups. |
| Mean Blood Magnetic Susceptibility (BMS) | 1 month | Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample. |
| Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | 2 months | Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). |
| Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 12 months - retrospective | Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed. |
| Mean Number of Erythrocyte Units Transfused in Last 12 Months | 12 months - retrospective | Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed. |
| Mean Quality of Life (QOL) Scores | 1 month | Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability. |
| Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | 1 month | Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high. |
| Investigator Treatment Decisions Based on MRI Results | 2 months | Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?. |
| Percentage of Participants Transfused With Erythrocytes | 12 months - retrospective | Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed. |
| Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | 2 months | Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Magnetic Resonance Imaging (MRI) All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload. | 243 |
| Total | 243 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Abnormal test procedure | 1 |
| Overall Study | Death | 1 |
| Overall Study | Did not complete scan within 45 days | 2 |
| Overall Study | No show for MRI appointment | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Unable to make MRI appointment | 3 |
| Overall Study | Unable to tolerate MRI; claustrophobic | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Magnetic Resonance Imaging (MRI) |
|---|---|
| Age, Continuous | 52.8 Years STANDARD_DEVIATION 20.92 |
| Sex: Female, Male Female | 109 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 81 | 9 / 74 | 3 / 68 | 0 / 20 |
| serious Total, serious adverse events | 2 / 81 | 8 / 74 | 2 / 68 | 0 / 20 |
Outcome results
Primary
Cardiac Siderosis Severity
Cardiac siderosis severity was measured by MRI (T2\*). The severity grade of siderosis was tiered in 3 levels: mild (T2\* \>= 20ms), moderate (T2\* from 10 to 20ms), and severe (T2\* \<10ms). Mild cardiac siderosis, by the definitions used in this study, were equivalent to not having cardiac siderosis. Values were compared to published thresholds of iron overload to determine severity of transfusion siderosis in the participant population studied.
Time frame: 2 months
Population: Only participants with valid T2\* by MRI were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Cardiac Siderosis Severity | None | 89.9 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Cardiac Siderosis Severity | Severe | 5.7 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Cardiac Siderosis Severity | Moderate | 4.4 Percentage of participants |
| Thalassemia Major | Cardiac Siderosis Severity | Moderate | 11.8 Percentage of participants |
| Thalassemia Major | Cardiac Siderosis Severity | None | 77.6 Percentage of participants |
| Thalassemia Major | Cardiac Siderosis Severity | Severe | 10.5 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Cardiac Siderosis Severity | Moderate | 0.0 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Cardiac Siderosis Severity | None | 95.7 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Cardiac Siderosis Severity | Severe | 4.3 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Cardiac Siderosis Severity | None | 100.0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Cardiac Siderosis Severity | Severe | 0.0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Cardiac Siderosis Severity | Moderate | 0.0 Percentage of participants |
| Other Anaemias | Cardiac Siderosis Severity | Moderate | 1.5 Percentage of participants |
| Other Anaemias | Cardiac Siderosis Severity | None | 95.4 Percentage of participants |
| Other Anaemias | Cardiac Siderosis Severity | Severe | 3.1 Percentage of participants |
Primary
Percentage of Participants With Cardiac and Liver Iron Overload.
Hepatic iron overload (liver siderosis) and cardiac iron overload (cardiac siderosis) in patients with transfusional siderosis (Myelodysplastic syndrome (MDS), thalassaemia major, non-transfusion-dependent thalassaemia (NTDT) and other anaemias) were measured using MRI (R2 by FerriScan and T2\*, respectively).
Time frame: 2 months
Population: Only participants with valid T2\* by MRI and valid liver iron concentration (LIC) by MRI were included for the cardiac siderosis and liver siderosis analyses, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Cardiac and Liver Iron Overload. | Liver | 48 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Cardiac and Liver Iron Overload. | Cardiac | 10 Percentage of participants |
| Thalassemia Major | Percentage of Participants With Cardiac and Liver Iron Overload. | Cardiac | 22 Percentage of participants |
| Thalassemia Major | Percentage of Participants With Cardiac and Liver Iron Overload. | Liver | 33 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Cardiac and Liver Iron Overload. | Liver | 55 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Cardiac and Liver Iron Overload. | Cardiac | 4 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Cardiac and Liver Iron Overload. | Cardiac | 0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Cardiac and Liver Iron Overload. | Liver | 50 Percentage of participants |
| Other Anaemias | Percentage of Participants With Cardiac and Liver Iron Overload. | Liver | 57 Percentage of participants |
| Other Anaemias | Percentage of Participants With Cardiac and Liver Iron Overload. | Cardiac | 3 Percentage of participants |
Secondary
Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups
Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups). The mean data presented are mean estimates of log transformed data.
Time frame: 2 months
Population: Only participants with valid LIC by MRI were included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 11.30 mg Fe/g |
| Magnetic Resonance Imaging (MRI) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 13.22 mg Fe/g |
| Magnetic Resonance Imaging (MRI) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 8.73 mg Fe/g |
| Thalassemia Major | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | NA mg Fe/g |
| Thalassemia Major | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 8.09 mg Fe/g |
| Thalassemia Major | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 8.09 mg Fe/g |
| Melodysplastic Syndrome (MDS) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 10.28 mg Fe/g |
| Melodysplastic Syndrome (MDS) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 10.84 mg Fe/g |
| Melodysplastic Syndrome (MDS) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 11.40 mg Fe/g |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 12.38 mg Fe/g |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 19.76 mg Fe/g |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 5.00 mg Fe/g |
| Other Anaemias | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 10.92 mg Fe/g |
| Other Anaemias | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 12.28 mg Fe/g |
| Other Anaemias | Comparison of Liver Iron Concentration (LIC) Levels to Evaluate Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 13.64 mg Fe/g |
Secondary
Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups
Iron overload due to transfusion therapy was assessed based on chelation status of each participant (i.e. minimally exposed to chelator treatment and chelation-treated patient subgroups).
Time frame: 2 months
Population: Only participants with valid T2\* by MRI were included in the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 30.2 ms |
| Magnetic Resonance Imaging (MRI) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 28.25 ms |
| Magnetic Resonance Imaging (MRI) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 32.55 ms |
| Thalassemia Major | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | NA ms |
| Thalassemia Major | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 23.95 ms |
| Thalassemia Major | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 23.95 ms |
| Melodysplastic Syndrome (MDS) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 32.05 ms |
| Melodysplastic Syndrome (MDS) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 30.13 ms |
| Melodysplastic Syndrome (MDS) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 28.32 ms |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 32.69 ms |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 32.43 ms |
| Non-transfusion-dependent Anaemia (NTDT) | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 32.95 ms |
| Other Anaemias | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelation naïve/minimally exposed(n=75,0,27,11,37) | 32.66 ms |
| Other Anaemias | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Overall (n=228,76,69,18,65) | 30.76 ms |
| Other Anaemias | Comparison of T2* Levels to Evaluate the Severity of Iron Overload Due to Transfusion Therapy in Chelation-naïve and Chelation-treated Participant Subgroups | Chelator exposed (n=153,76,42,7,28) | 28.96 ms |
Secondary
Investigator Treatment Decisions Based on MRI Results
Treatment decisions were recorded after the investigator evaluated the MRI results, in order to assess the impact of such diagnostic test on the overall clinical management of participants with iron overload. Investigators answered the following question: Since the MRI scan, have you changed or are planning to change the management of iron in your subject?.
Time frame: 2 months
Population: Participants, for whom treatment decision questionnaire results were provided and for whom MRI results were available, were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Investigator Treatment Decisions Based on MRI Results | Answer = yes | 42.4 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Investigator Treatment Decisions Based on MRI Results | Answer = no | 57.6 Percentage of participants |
Secondary
Mean Blood Magnetic Susceptibility (BMS)
Blood samples were collected to assess BMS. The measurement represents absolute magnetic susceptibility at 1 month. Whole blood magnetic susceptibility was calculated by the addition of the dry weight susceptibility and the contribution of the water driven from the sample.
Time frame: 1 month
Population: Participants with BMS values were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Blood Magnetic Susceptibility (BMS) | -6.18 emu/g wet wt/Oe | Standard Deviation 0.147 |
Secondary
Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events
Mean cardiac T2\* according to the presence or absence of cardiac events was assessed for all participant subgroups. The mean data presented are mean estimates of log transformed data.
Time frame: 12 months - retrospective
Population: Participants with valid T2\* by MRI results were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events | Cardiac event in past 12 months = yes (n=12) | 1.546 log10 (ms) | Standard Deviation 0.0979 |
| Magnetic Resonance Imaging (MRI) | Mean Cardiac T2* According to the Presence or Absence of Retrospective Cardiac Events | Cardiac event in the past 12 months = no (n=226) | 1.445 log10 (ms) | Standard Deviation 0.2188 |
Secondary
Mean LIC According to the Presence or Absence of Retrospective Hepatic Events
Mean LIC according to the presence or absence of hepatic events was assessed for all participant subgroups.
Time frame: 12 months - retrospective
Population: Participants with LIC by MRI were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean LIC According to the Presence or Absence of Retrospective Hepatic Events | Hepatic event in past 12 months = yes (n=7) | 17.51 mg Fe/g | Standard Deviation 15.292 |
| Magnetic Resonance Imaging (MRI) | Mean LIC According to the Presence or Absence of Retrospective Hepatic Events | Hepatic event in past 12 months = no (n=221) | 10.08 mg Fe/g | Standard Deviation 10.95 |
Secondary
Mean Number of Erythrocyte Units Transfused in Last 12 Months
Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
Time frame: 12 months - retrospective
Population: Participants with 'number of units transfused' data were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Number of Erythrocyte Units Transfused in Last 12 Months | 33.3 number of units transfused | Standard Deviation 21 |
| Thalassemia Major | Mean Number of Erythrocyte Units Transfused in Last 12 Months | 41.4 number of units transfused | Standard Deviation 9.5 |
| Melodysplastic Syndrome (MDS) | Mean Number of Erythrocyte Units Transfused in Last 12 Months | 34.7 number of units transfused | Standard Deviation 25.6 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Number of Erythrocyte Units Transfused in Last 12 Months | 8.4 number of units transfused | Standard Deviation 12.2 |
| Other Anaemias | Mean Number of Erythrocyte Units Transfused in Last 12 Months | 24.8 number of units transfused | Standard Deviation 21.5 |
Secondary
Mean Quality of Life (QOL) Scores
Quality of life was assessed using the Short Form 36 (SF-36) Health Survey. The SF-36 consists of 8 sub-scales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The raw sores of the 8 scales are transformed to a 0 - 100 scale where 0 indicates maximum disability and 100 indicates no disability. There also are two physical and mental health summary measures. Each summary measure is the mean average of the 4 associated sub-scale scores. The range for each summary measure is 0 to 100 where 0 represents maximum disability and 100 represents no disability.
Time frame: 1 month
Population: Only participants with data for each subscale were included in the analysis for that subscale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Role physical | 42.54 units on a scale | Standard Deviation 10.895 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Role emotional | 43.83 units on a scale | Standard Deviation 12.977 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Mental health | 47.84 units on a scale | Standard Deviation 11.149 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Bodily pain | 48.41 units on a scale | Standard Deviation 10.969 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Mental component summary | 46.76 units on a scale | Standard Deviation 11.622 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | General health | 41.65 units on a scale | Standard Deviation 9.909 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Physical functioning | 43.10 units on a scale | Standard Deviation 11.471 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Vitality | 45.59 units on a scale | Standard Deviation 10.267 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Social functioning | 44.99 units on a scale | Standard Deviation 11.075 |
| Magnetic Resonance Imaging (MRI) | Mean Quality of Life (QOL) Scores | Physical component summary | 43.48 units on a scale | Standard Deviation 9.808 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Mental component summary | 49.58 units on a scale | Standard Deviation 10.354 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Bodily pain | 50.48 units on a scale | Standard Deviation 11.084 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Physical component summary | 48.75 units on a scale | Standard Deviation 7.809 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | General health | 44.82 units on a scale | Standard Deviation 9.365 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Social functioning | 48.98 units on a scale | Standard Deviation 9.869 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Role emotional | 48.99 units on a scale | Standard Deviation 11.236 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Role physical | 49.51 units on a scale | Standard Deviation 8.836 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Vitality | 50.18 units on a scale | Standard Deviation 9.277 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Mental health | 50.09 units on a scale | Standard Deviation 11.24 |
| Thalassemia Major | Mean Quality of Life (QOL) Scores | Physical functioning | 49.79 units on a scale | Standard Deviation 9.144 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Physical component summary | 37.55 units on a scale | Standard Deviation 8.748 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Vitality | 42.41 units on a scale | Standard Deviation 9.19 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Role physical | 36.71 units on a scale | Standard Deviation 9.462 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Bodily pain | 45.52 units on a scale | Standard Deviation 10.75 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Physical functioning | 35.67 units on a scale | Standard Deviation 9.791 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Mental component summary | 45.91 units on a scale | Standard Deviation 10.349 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Mental health | 46.69 units on a scale | Standard Deviation 9.495 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Role emotional | 40.11 units on a scale | Standard Deviation 13.101 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | General health | 39.48 units on a scale | Standard Deviation 9.595 |
| Melodysplastic Syndrome (MDS) | Mean Quality of Life (QOL) Scores | Social functioning | 42.37 units on a scale | Standard Deviation 10.486 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Physical component summary | 50.34 units on a scale | Standard Deviation 6.392 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Physical functioning | 49.37 units on a scale | Standard Deviation 7.576 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Role physical | 46.46 units on a scale | Standard Deviation 8.717 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Bodily pain | 54.66 units on a scale | Standard Deviation 7.773 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | General health | 43.23 units on a scale | Standard Deviation 8.893 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Vitality | 48.95 units on a scale | Standard Deviation 8.424 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Social functioning | 46.43 units on a scale | Standard Deviation 9.905 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Role emotional | 47.03 units on a scale | Standard Deviation 10.552 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Mental health | 48.74 units on a scale | Standard Deviation 9.846 |
| Non-transfusion-dependent Anaemia (NTDT) | Mean Quality of Life (QOL) Scores | Mental component summary | 47.47 units on a scale | Standard Deviation 10.832 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Mental health | 46.12 units on a scale | Standard Deviation 12.632 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Social functioning | 42.67 units on a scale | Standard Deviation 12.043 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Vitality | 42.67 units on a scale | Standard Deviation 10.757 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | General health | 39.80 units on a scale | Standard Deviation 10.239 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Physical component summary | 41.93 units on a scale | Standard Deviation 9.524 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Bodily pain | 47.60 units on a scale | Standard Deviation 10.815 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Role physical | 39.44 units on a scale | Standard Deviation 10.229 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Physical functioning | 41.56 units on a scale | Standard Deviation 11.139 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Role emotional | 40.89 units on a scale | Standard Deviation 13.32 |
| Other Anaemias | Mean Quality of Life (QOL) Scores | Mental component summary | 44.08 units on a scale | Standard Deviation 13.822 |
Secondary
Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events
Mean serum ferritin according to the presence or absence of cardiac events was assessed for all participant subgroups.
Time frame: 12 months - retrospective
Population: Participants with serum ferritin values and previous cardiac events data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events | Cardiac event in past 12 months = yes (n=12) | 2153.6 ng/mL | Standard Deviation 1878.6 |
| Magnetic Resonance Imaging (MRI) | Mean Serum Ferritin According to the Presence or Absence of Retrospective Cardiac Events | Cardiac event in past 12 months = no (n=226) | 2150.2 ng/mL | Standard Deviation 1914.5 |
Secondary
Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events
Mean serum ferritin according to the presence or absence of hepatic events was assessed for all participant subgroups.
Time frame: 12 months - retrospective
Population: Participants with serum ferritin values and previous hepatic events data were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events | Hepatic event in the past 12 months = yes (n=8) | 3302.8 ng/mL | Standard Deviation 2684.3 |
| Magnetic Resonance Imaging (MRI) | Mean Serum Ferritin According to the Presence or Absence of Retrospective Hepatic Events | Hepatic event in the past 12 months = no (n=231) | 2124.1 ng/mL | Standard Deviation 1879.2 |
Secondary
Percentage of Participants Transfused With Erythrocytes
Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
Time frame: 12 months - retrospective
Population: Participants with a erythrocyte transfusion history were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Magnetic Resonance Imaging (MRI) | Percentage of Participants Transfused With Erythrocytes | 95.0 Percentage of participants |
| Thalassemia Major | Percentage of Participants Transfused With Erythrocytes | 100.0 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants Transfused With Erythrocytes | 100.0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants Transfused With Erythrocytes | 36.8 Percentage of participants |
| Other Anaemias | Percentage of Participants Transfused With Erythrocytes | 100.0 Percentage of participants |
Secondary
Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy
Adherence of participants was assessed using an adherence questionnaire. Adherence questionnaires were completed only by participants who received chelating agents. Participants answered yes or no to 6 statements such as Forgot to take pills. Based on the responses to these questions, adherence was classified as low, medium or high.
Time frame: 1 month
Population: Participants who were on iron chelator therapy at screening, and had answered at least one question on the questionnaire and had sufficient information to score the questionnaire, were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Low | 27.7 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | High | 10.6 Percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Medium | 61.7 Percentage of participants |
| Thalassemia Major | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Medium | 57.7 Percentage of participants |
| Thalassemia Major | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Low | 32.1 Percentage of participants |
| Thalassemia Major | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | High | 10.3 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Medium | 73.5 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Low | 11.8 Percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | High | 14.7 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Low | 75.0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | High | 0.0 Percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Medium | 25.0 Percentage of participants |
| Other Anaemias | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Medium | 64.0 Percentage of participants |
| Other Anaemias | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | Low | 28.0 Percentage of participants |
| Other Anaemias | Percentage of Participants With Low Medium or High Adherence to Iron Chelator Therapy | High | 8.0 Percentage of participants |
Secondary
Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days
Transfusion requirement in participants with acquired anaemias with history of receiving chelation therapy was assessed.
Time frame: 12 months - retrospective
Population: Participants with data on time since their most recent transfusion were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 30 - < 60 days | 5.8 percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | < 7 days | 43.1 percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | >= 60 days | 18.2 percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 7 - < 14 days | 12.9 percentage of participants |
| Magnetic Resonance Imaging (MRI) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 14 - < 30 days | 20.0 percentage of participants |
| Thalassemia Major | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 30 - < 60 days | 2.5 percentage of participants |
| Thalassemia Major | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 14 - < 30 days | 22.2 percentage of participants |
| Thalassemia Major | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 7 - < 14 days | 2.5 percentage of participants |
| Thalassemia Major | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | >= 60 days | 0.0 percentage of participants |
| Thalassemia Major | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | < 7 days | 72.8 percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 14 - < 30 days | 14.1 percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | < 7 days | 31.0 percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 7 - < 14 days | 28.2 percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 30 - < 60 days | 9.9 percentage of participants |
| Melodysplastic Syndrome (MDS) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | >= 60 days | 16.9 percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | >= 60 days | 57.1 percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | < 7 days | 14.3 percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 30 - < 60 days | 14.3 percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 14 - < 30 days | 0.0 percentage of participants |
| Non-transfusion-dependent Anaemia (NTDT) | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 7 - < 14 days | 14.3 percentage of participants |
| Other Anaemias | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 14 - < 30 days | 25.8 percentage of participants |
| Other Anaemias | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 30 - < 60 days | 4.5 percentage of participants |
| Other Anaemias | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | < 7 days | 22.7 percentage of participants |
| Other Anaemias | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | >= 60 days | 37.9 percentage of participants |
| Other Anaemias | Percentage of Participants With Time Since Most Recent Transfuison of <7 Days, 7 to < 14 Days, 14 to < 30 Days, 30 to < 60 Days or >= 60 Days | 7 - < 14 days | 9.1 percentage of participants |