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Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®) compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
IDA is highly prevalent condition in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure or surgery. IDA can have a substantial medical and quality of life (QoL) burden. Treatment of subjects diagnosed with IDA includes controlling the bleeding and replenishing lost iron.
This study was designed to evaluate the safety and efficacy of iron isomaltoside/ferric derisomaltose compared with iron sucrose in subjects diagnosed with IDA. In a subfraction of 35 subjects treated with iron isomaltoside/ferric derisomaltose, ECG and iron will be frequently measured.
The study subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or iron sucrose (200 mg IV injections at baseline and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline; a cumulative dose of 1000 mg was recommended). The study subjects were monitored for up to 8 weeks from baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Experimental | Administered IV |
|
| Iron sucrose | Active Comparator | Administered IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside/ferric derisomaltose | Drug | Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hb) From Baseline to Week 8 | Efficacy Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) . Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores. | Baseline to week 8 |
| Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions. | Baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Cardiovascular Adverse Events (AEs) | Safety Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8. The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). The potential cardiovascular AEs included the following:
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs. |
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Inclusion criteria includes:
Exclusion Criteria includes :
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| Name | Affiliation | Role |
|---|---|---|
| Pharmacosmos A/S Clinical and Non-clinical Research | Pharmacosmos A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmacosmos Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Pharmacosmos Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31243803 | Result | Auerbach M, Henry D, Derman RJ, Achebe MM, Thomsen LL, Glaspy J. A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Am J Hematol. 2019 Sep;94(9):1007-1014. doi: 10.1002/ajh.25564. Epub 2019 Jul 13. | |
| Result | Auerbach M and Lykke LL. A single infusion of iron isomaltoside 1000 allows a more rapid hemoglobin increment than multiple doses of iron sucrose with a similar safety profile in patients with iron deficiency anemia. Blood 2018 132:2334; doi: https://doi.org/10.1182/blood-2018-99-110199 |
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Subjects who did not have a documented history of intolerance of oral iron for at least 1 month within the last 9 months had a run-in period. During the run-in period, the subject received oral iron for up to 1 month in order to document intolerance or lack of response to oral iron.Subjects were monitored for AEs indicative of iron intolerance.
A total of 3108 subjects were screened and 1512 subjects were randomised in the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg at the baseline visit. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Jan 3, 2020 |
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|
| Iron sucrose | Drug | Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended. |
|
|
| Baseline, week 1, 2, and 8 |
| Time to First Composite Cardiovascular Safety AE | Safety Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint. Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. | Baseline, week 1, 2, 4, and 8 |
| S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Safety Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8. | Baseline, week 1, 2, 4, and 8 |
| Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8 | Efficacy Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8). | Baseline, week 1, 2, 4, and 8 |
| Time to Change in Hb Concentration ≥2 g/dL | Efficacy Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8). For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured. | Baseline, week 1, 2, 4, and 8 |
| Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 | Efficacy Hb concentration of >12 g/dL at any time from week 1 to week 8. Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8. | Week 1 to week 8 |
| Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 | Efficacy Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8. | Week 1 to week 8 |
| S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 | Efficacy Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8. | Week 1 to week 8 |
| Change in Hb Concentration From Baseline to Week 1, 2, and 4 | Efficacy Change in Hb concentration from baseline to week 1, 2, and 4. | Baseline, week 1, 2, and 4 |
| Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8 | Efficacy Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8. | Baseline, week 1, 2, 4, and 8 |
| Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 | Efficacy Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron. | Baseline, week 1, 2, 4, and 8 |
| Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8 | Efficacy Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8. | Baseline, week 1, 2, 4, and 8 |
| Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 | Efficacy Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52. A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated. Total score was calculated as shown below: Total score= Sum of individual scores x 13 / Number of items answered | Baseline, week 1, 2, and 8 |
| Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | Baseline |
| Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | Baseline |
| Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | Baseline |
| Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | Baseline |
| Health Care Resource Use Questionnaire | Pharmacoeconomics Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group). | Baseline |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Pharmacosmos Investigational Site | Guntersville | Alabama | 35976 | United States |
| Pharmacosmos Investigational Site | Phoenix | Arizona | 85018 | United States |
| Pharmacosmos Investigational Site | Little Rock | Arkansas | 72204 | United States |
| Pharmacosmos Investigational Site | Little Rock | Arkansas | 72205 | United States |
| Pharmacosmos Investigational Site | Foothill Ranch | California | 92610 | United States |
| Pharmacosmos Investigational Site 1 | La Mesa | California | 91942 | United States |
| Pharmacosmos Investigational Site 2 | La Mesa | California | 91942 | United States |
| Pharmacosmos Investigational Site | Long Beach | California | 90806 | United States |
| Pharmacosmos Investigational Site | National City | California | 91950 | United States |
| Pharmacosmos Investigational Site 1 | Northridge | California | 91324 | United States |
| Pharmacosmos Investigational Site 2 | Northridge | California | 91324 | United States |
| Pharmacosmos Investigational Site | Oceanside | California | 92056 | United States |
| Pharmacosmos Investigational Site | Quartz Hill | California | 93536 | United States |
| Pharmacosmos Investigational Site | Rialto | California | 92377 | United States |
| Pharmacosmos Investigational Site | Riverside | California | 92501 | United States |
| Pharmacosmos Investigational Site | San Diego | California | 92103 | United States |
| Pharmacosmos Investigational Site | San Diego | California | 92117 | United States |
| Pharmacosmos Investigational Site | San Marcos | California | 92078 | United States |
| Pharmacosmos Investigational Site | Whittier | California | 90603 | United States |
| Pharmacosmos Investigational Site | Plainville | Connecticut | 06062 | United States |
| Pharmacosmos Investigational Site | Aventura | Florida | 33180 | United States |
| Pharmacosmos Investigational Site | Boynton Beach | Florida | 33426 | United States |
| Pharmacosmos Investigational Site 1 | Doral | Florida | 33166 | United States |
| Pharmacosmos Investigational Site 2 | Doral | Florida | 33166 | United States |
| Pharmacosmos Investigational Site | Doral | Florida | 33172 | United States |
| Pharmacosmos Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Pharmacosmos Investigational Site | Hialeah | Florida | 33012 | United States |
| Pharmacosmos Investigational Site | Hialeah | Florida | 33015 | United States |
| Pharmacosmos Investigational Site | Hialeah | Florida | 33016 | United States |
| Pharmacosmos Investigational Site | Hollywood | Florida | 33024 | United States |
| Pharmacosmos Investigational Site | Jacksonville | Florida | 32204 | United States |
| Pharmacosmos Investigational Site | Kissimmee | Florida | 34741 | United States |
| Pharmacosmos Investigational Site | Lake City | Florida | 32024 | United States |
| Pharmacosmos Investigational Site | Lake Worth | Florida | 33461 | United States |
| Pharmacosmos Investigational Site | Lake Worth | Florida | 33467 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33015 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33126 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33130 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33135 | United States |
| Pharmacosmos Investigational Site 1 | Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site 2 | Miami | Florida | 33144 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33147 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33155 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33165 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33173 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33174 | United States |
| Pharmacosmos Investigational Site | Miami | Florida | 33185 | United States |
| Pharmacosmos Investigational Site 1 | Miami Lakes | Florida | 33014 | United States |
| Pharmacosmos Investigational Site 2 | Miami Lakes | Florida | 33014 | United States |
| Pharmacosmos Investigational Site | Miami Lakes | Florida | 33014 | United States |
| Pharmacosmos Investigational Site 1 | Naples | Florida | 34102 | United States |
| Pharmacosmos Investigational Site 2 | Naples | Florida | 34102 | United States |
| Pharmacosmos Investigational Site | Palmetto Bay | Florida | 33157 | United States |
| Pharmacosmos Investigational Site | Plantation | Florida | 33324 | United States |
| Pharmacosmos Investigational Site | West Palm Beach | Florida | 33409 | United States |
| Pharmacosmos Investigational Site | Champaign | Illinois | 61820 | United States |
| Pharmacosmos Investigational Site | Joliet | Illinois | 60435 | United States |
| Pharmacosmos Investigational Site | Palos Heights | Illinois | 60463 | United States |
| Pharmacosmos Investigational Site | Terre Haute | Indiana | 47802 | United States |
| Pharmacosmos Investigational Site | Wichita | Kansas | 67214 | United States |
| Pharmacosmos Investigational Site | Owensboro | Kentucky | 42303 | United States |
| Pharmacosmos Investigational Site | Baton Rouge | Louisiana | 70809 | United States |
| Pharmacosmos Investigational Site | Marrero | Louisiana | 70072 | United States |
| Pharmacosmos Investigational Site | Metairie | Louisiana | 70006 | United States |
| Pharmacosmos Investigational Site | New Orleans | Louisiana | 70125 | United States |
| Pharmacosmos Investigational Site | Shreveport | Louisiana | 71103 | United States |
| Pharmacosmos Investigational Site | Bethesda | Maryland | 20817 | United States |
| Pharmacosmos Investigational Site | Hagerstown | Maryland | 21740 | United States |
| Pharmacosmos Investigational Site | Towson | Maryland | 21204 | United States |
| Pharmacosmos Investigational Site | Fall River | Massachusetts | 02720 | United States |
| Pharmacosmos Investigational Site | Grand Rapids | Michigan | 49525 | United States |
| Pharmacosmos Investigational Site | Saginaw | Michigan | 48604 | United States |
| Pharmacosmos Investigational Site | Troy | Michigan | 48085 | United States |
| Pharmacosmos Investigational Site | Florissant | Missouri | 63031 | United States |
| Pharmacosmos Investigational Site | Omaha | Nebraska | 68134 | United States |
| Pharmacosmos Investigational Site | Las Vegas | Nevada | 89109 | United States |
| Pharmacosmos Investigational Site | Neptune City | New Jersey | 07753 | United States |
| Pharmacosmos Investigational Site | Plainsboro | New Jersey | 08536 | United States |
| Brooklyn | New York | 11235 | United States |
| Pharmacosmos Investigational Site 1 | East Setauket | New York | 11733 | United States |
| Pharmacosmos Investigational Site 2 | East Setauket | New York | 11733 | United States |
| Pharmacosmos Investigational Site | New York | New York | 10016 | United States |
| Pharmacosmos Investigational Site | Wilmington | North Carolina | 28401 | United States |
| Pharmacosmos Investigational Site | Wilmington | North Carolina | 28403 | United States |
| Pharmacosmos Investigational Site | Beavercreek | Ohio | 45431 | United States |
| Pharmacosmos Investigational Site | Canton | Ohio | 44718 | United States |
| Pharmacosmos Investigational Site | Centerville | Ohio | 45459 | United States |
| Pharmacosmos Investigational Site | Cincinnati | Ohio | 45206 | United States |
| Pharmacosmos Investigational Site | Columbus | Ohio | 43231 | United States |
| Pharmacosmos Investigational Site | Norman | Oklahoma | 73069 | United States |
| Pharmacosmos Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| Pharmacosmos Investigational Site | Jenkintown | Pennsylvania | 19046 | United States |
| Pharmacosmos Investigational Site | Columbia | South Carolina | 29209 | United States |
| Pharmacosmos Investigational Site | Myrtle Beach | South Carolina | 29572 | United States |
| Pharmacosmos Investigational Site | Chattanooga | Tennessee | 37404 | United States |
| Pharmacosmos Investigational Site | Franklin | Tennessee | 37067 | United States |
| Pharmacosmos Investigational Site | Knoxville | Tennessee | 37923 | United States |
| Pharmacosmos Investigational Site | Memphis | Tennessee | 38104 | United States |
| Pharmacosmos Investigational Site | Austin | Texas | 78704 | United States |
| Pharmacosmos Investigational Site | Baytown | Texas | 77521 | United States |
| Pharmacosmos Investigational Site | Beaumont | Texas | 77702 | United States |
| Pharmacosmos Investigational Site | Corsicana | Texas | 75110 | United States |
| Pharmacosmos Investigational Site | DeSoto | Texas | 75115 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77030 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77079 | United States |
| Pharmacosmos Investigational Site | Houston | Texas | 77099 | United States |
| Pharmacosmos Investigational Site | McAllen | Texas | 78503 | United States |
| Pharmacosmos Investigational Site | San Antonio | Texas | 78215 | United States |
| Pharmacosmos Investigational Site | San Antonio | Texas | 78217 | United States |
| Pharmacosmos Investigational Site | Ogden | Utah | 84405 | United States |
| Pharmacosmos Investigational Site | Chesapeake | Virginia | 23320 | United States |
| Pharmacosmos Investigational Site | Tacoma | Washington | 98405 | United States |
| Iron Sucrose |
Iron sucrose (Venofer®) was the comparator in this trial. Subjects received iron sucrose (Venofer®), 200 mg IV injection up to a maximum of 5 intravenous injections within the first 2 weeks, starting at baseline (a cumulative dose of 1000 mg was recommended). |
| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV |
| BG001 | Iron Sucrose | Iron sucrose, administered IV |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Current smoker | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Hemoglobin (Hb) From Baseline to Week 8 | Efficacy Evaluate the effect on the hemoglobin (Hb) level following treatment with iron isomaltoside/ferric derisomaltose vs iron sucrose in subjects with iron deficiency anaemia (IDA) . Response was defined as change from baseline in hemoglobin (Hb) to week 8, i.e. ability to increase Hb in subjects with IDA, when oral iron preparations were ineffective or could not be used or in whom the screening Hb measurement in Investigators' opinion were sufficiently low to require rapid repletion of iron stores. | Intention to treat (ITT). All randomised subjects. | Posted | Least Squares Mean | 95% Confidence Interval | g/dL | Baseline to week 8 |
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| Primary | Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions | Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated. The hypersensitivity reactions that were included in the analysis were those that started on or after the first dose of randomised treatment (i.e. treatment emergent). The terms used to define hypersensitivity were those specified by the Standardised MedDRA Queries (SMQ) for hypersensitivity, plus four additional terms: loss of consciousness, seizure, syncope, unresponsiveness. The potential hypersensitivity AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). Results show only those participants that had adjudicated and confirmed serious or severe hypersensitivity reactions. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline to week 8 |
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| Secondary | Composite Cardiovascular Adverse Events (AEs) | Safety Results show the composite cardiovascular adverse events (AEs), that started on or after the first dose of randomised treatment (i.e. treatment emergent) up to week 8. The reported potential cardiovascular AEs were adjudicated in a blinded fashion by an independent Clinical Endpoint Adjudication Committee (CEAC). The potential cardiovascular AEs included the following:
Results show only those participants that had adjudicated and confirmed treatment-emergent composite cardiovascular AEs. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline, week 1, 2, and 8 |
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| Secondary | Time to First Composite Cardiovascular Safety AE | Safety Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. Only the adjudicated and confirmed composite cardiovascular safety AEs, as judged by the CEAC, were considered for this endpoint. Time to first composite cardiovascular AE was defined as the actual time in days from first dose of treatment until the date of the composite cardiovascular AE. For subjects not reporting a composite cardiovascular AE, the time was censored at the date of the last attended visit. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Median | 95% Confidence Interval | Week | Baseline, week 1, 2, 4, and 8 |
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| Secondary | S-phosphate <2 mg/dL at Any Time From Baseline to Week 1, 2, 4, and 8 | Safety Results show the number of subjects who had s-phosphate <2 mg/dL at any time from baseline to week 1, 2, 4, or 8. | Safety analysis set. All randomised subjects who received at least one dose of the investigational product. | Posted | Count of Participants | Participants | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Hb Concentration Increase of ≥2 g/dL From Baseline to Week 1, 2, 4, and 8 | Efficacy Results show responders to the treatment. A subject was considered a Hb responder to a certain week if an increase in Hb of at least 2 g/dL from baseline to the week in question was observed (week 1, 2, 4, and 8). | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Time to Change in Hb Concentration ≥2 g/dL | Efficacy Time to change in Hb concentration ≥2 g/dL. Subjects who achieved Hb concentration increase of ≥2 g/dL (from baseline to week 1, 2, 4, or 8). For responders, time to Hb response was defined as the scheduled time from baseline until the visit where the first Hb response was measured. | ITT. All randomised subjects. | Posted | Median | 95% Confidence Interval | Days | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Hb Concentration of >12 g/dL at Any Time From Week 1 to Week 8 | Efficacy Hb concentration of >12 g/dL at any time from week 1 to week 8. Results show the number of participants who achieved Hb concentration of >12 g/dL at any time from week 1 to week 8. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| Secondary | Hb Concentration Increase of ≥2 g/dL at Any Time From Week 1 to Week 8 | Efficacy Results show the number of participants who achieved Hb concentration increase of ≥2 g/dL at any time from week 1 to week 8. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| Secondary | S-Ferritin Concentration of ≥100 ng/mL and Transferrin Saturation (TSAT) of 20-50% at Any Time From Week 1 to Week 8 | Efficacy Proportion of subjects reaching the composite endpoint of s-ferritin concentration ≥100 ng/mL and TSAT of 20-50% at any time from week 1 to 8. | ITT. All randomised subjects. | Posted | Count of Participants | Participants | Week 1 to week 8 |
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| Secondary | Change in Hb Concentration From Baseline to Week 1, 2, and 4 | Efficacy Change in Hb concentration from baseline to week 1, 2, and 4. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | g/dL | Baseline, week 1, 2, and 4 |
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| Secondary | Change in S-ferritin Concentration From Baseline to Weeks 1, 2, 4, and 8 | Efficacy Change in s-ferritin concentration from baseline to weeks 1, 2, 4, and 8. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | ng/mL | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Change in Transferrin Saturation (TSAT) From Baseline to Week 1, 2, 4, and 8 | Efficacy Changes in transferrin saturation (TSAT) from baseline to week 1, 2, 4, and 8. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | percentage of saturation | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Change in Concentrations of Serum Iron (S-iron) From Baseline to Week 1, 2, 4, and 8 | Efficacy Changes in the concentrations of serum iron (s-iron) from baseline to week 1, 2, 4, and 8. | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | μg/dL | Baseline, week 1, 2, 4, and 8 |
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| Secondary | Change in Fatigue Symptoms From Baseline to Week 1, 2, and 8 | Efficacy Change in fatigue symptoms from baseline to week 1, 2, and 8 was measured by the Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale. The Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale consisted of 13 items ranging from 0 (not at all) to 4 (very much), except items #7 and #8 which are reversed scored. The total score range is 0-52. A score of less than 30 indicated severe fatigue, and the higher the score, the better outcome/quality of life (QoL). If more than 50% of the items for a subject at a given visit were missing, the total score was not calculated. Total score was calculated as shown below: Total score= Sum of individual scores x 13 / Number of items answered | ITT. All randomised subjects. | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 1, 2, and 8 |
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| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Cost of Public Transport/Taxi And Parking | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | ITT. All randomised subjects. | Posted | Median | Full Range | US dollars ($) | Baseline |
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| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Return Journey by Car | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | ITT. All randomised subjects. | Posted | Median | Full Range | miles | Baseline |
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| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Time Spent on Visit/Helping on Visit | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | ITT. All randomised subjects. | Posted | Median | Full Range | Hours | Baseline |
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| Secondary | Intervals in Screening for Diabetic Retinopathy (ISDR) Questionnaire, Participants/Others Who Took Time Off Work to Attend Visits | Pharmacoeconomics The Intervals in Screening for Diabetic Retinopathy (ISDR) questionnaire at the baseline visit assessed the resources used by subjects to receive treatment. Resources used on other trial activities were not included. ISDR responses were summarised using descriptive statistics. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the 2 treatment groups is different, however, (i.e. up to a factor 5 in the iron sucrose treatment group). | ITT. All randomised subjects. | Posted | Number | participants | Baseline |
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| Secondary | Health Care Resource Use Questionnaire | Pharmacoeconomics Resources used by the health care staff (per administration), measured by the health care resource use questionnaire. The questionnaire assessed the time used by the health care staff during administration of the investigational product and the administration time (including the observational time). The health care participants included in the evaluation were: investigator, pharmacist, physician, study coordinator, study nurse. The data for this endpoint show the responses at baseline for both treatment groups. The frequency of drug administration between the treatment groups is different (i.e. up to a factor 5 more frequent in the iron sucrose treatment group). | ITT. All randomised subjects. | Posted | Median | Full Range | hours | Baseline |
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From the time a subjects had signed the informed consent form (CRF) and until they had completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 8 weeks (or shorted if the trial was discontinued). Overall, eligible subjects participated in the trial for approximately 10-15 weeks (including a 14-day screening period and if necessary a run-in period).
AEs were described in a precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. Furthermore, the Investigator assessed an AE regarding seriousness, severity, relatedness, and outcome.
Of the 1009 subjects in the iron isomaltoside/ferric derisomaltose arm and 503 in the iron sucrose arm, 989 subjects and 494 subjects received treatment, respectively, and were included in the safety population (i.e. at risk).
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 | Iron Isomaltoside/Ferric Derisomaltose | Iron isomaltoside/ferric derisomaltose, administered IV | 1 | 989 | 21 | 989 | 31 | 989 |
| EG001 | Iron Sucrose | Iron sucrose, administered IV | 0 | 494 | 13 | 494 | 16 | 494 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal adhesions faecaloma | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Peptic ulcer | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 21.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Hyperinsulinaemic hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 21.0 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
Institution may publish the study results. Before submission for publication or presentation, Institution shall allow Sponsor not less than 90 days to review any manuscript and not less than 30 days to review any poster presentation, abstract, or any other written or oral material which describes or discloses the study results. If sponsor so requests in writing, Institution shall withhold any publication or presentation for an additional 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical trial disclosure desk | Pharmacosmos A/S | +45 5948 5935 | trial@pharmacosmos.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2018 | Jan 3, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
| C000718030 | ferric derisomaltose |
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
Not provided
Not provided
| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Hispanic |
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| Mix race (Black & White) |
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| Caucasian |
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| Haitian |
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| Latino |
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| Other (not declared) |
|
| NO |
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| Non-Inferiority |
Non-inferiority could be claimed if the lower bound of the 95% confidence interval (CI) was above -0.5 g/dL. |
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|---|---|
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