Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA

• Sponsor: American Regent, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03523117
• Collaborator: (none)
• Enrollment: 79
• Locations: 16
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.

Condition or Disease	Intervention/Treatment	Phase
Iron Deficiency Anemia	Drug: Ferric carboxymaltose; Drug: Ferrous Sulfate	Phase 3

Detailed Description

This is a Phase III, multicenter, randomized, active-controlled study that compares the efficacy and safety of FCM to oral iron in pediatric participants with IDA and a documented history of an inadequate response to oral iron therapy at least 8 weeks (56 days) prior to randomization.

Participants who satisfy the inclusion requirements and no exclusion criteria will be eligible to participate in this study and enter into a screening phase to confirm eligibility. Randomization will occur via the Interactive Response Technology (IRT) system in a 1:1 ratio to either Group A, participants receiving FCM, or Group B, participants receiving oral iron (oral solution drops, elixir or oral tablets). Randomization will be stratified by baseline Hgb (<10, ≥10 g/dL) and age (1 to <12 years and ≥12 to 17 years).

The oral ferrous sulfate formulation received will be based on the participant's age, such that infants and children (1 to <4 years of age) will receive ferrous sulfate drops, children (≥4 to <12 years of age) will receive ferrous sulfate elixir, and adolescents (≥12 to 17 years of age) will receive ferrous sulfate tablets. Participants who experience adverse clinical symptoms due to the oral iron during the treatment phase may have a weight-based dose of ferrous sulfate reduced from 6 mg/kg to 3 mg/kg. If the participant is receiving tablets, the dose will be reduced from one tablet taken twice daily to one tablet per day.

Once randomized, all participants will return for efficacy and safety evaluations, including adverse events and laboratory assessments, on Days 7, 14, 28, and 35. Additional pharmacokinetic sampling and analyses will be performed for participants receiving FCM on Days 0 and 7.

Study Design

• Study Type: Interventional
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Active-Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia
• Actual Study Start Date: Jan 31, 2019
• Actual Primary Completion Date: Dec 22, 2020
• Actual Study Completion Date: Jan 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ferric Caroboxymaltose Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes.	Drug: Ferric carboxymaltose; Intravenous iron; Other Names: Injectafer Ferinject
Active Comparator: Oral Ferrous Sulfate Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron.	Drug: Ferrous Sulfate; oral iron therapy; Other Names: oral iron

Outcome Measures

Primary Outcome Measures

1. Change in Hemoglobin g/dL [Baseline to day 35]

   Change in hemoglobin g/dL from baseline to day 35 will be analyzed using parametric analysis of covariance (ANCOVA). The model will include terms for the randomization strata (hemoglobin and age categories), baseline hemoglobin, as well as treatment group. Baseline hemoglobin will be defined as the last hemoglobin obtained before randomization.

Secondary Outcome Measures

1. Change in Ferritin µg/L From Baseline to Day 35 [Baseline to day 35]

   Change in ferritin µg/L from baseline to day 35 was analyzed using parametric analysis of covariance (ANCOVA). The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a covariate.

2. Change in TSAT (%) From Baseline to Day 35 [Baseline to day 35]

   Change in TSAT (%) from baseline to day 35 was analyzed using parametric analysis of covariance (ANCOVA). The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a covariate

3. Change in Reticulocyte Hemoglobin (Picograms) Content From Baseline to Day 35 [Baseline to day 35]

   Change in reticulocyte hemoglobin (picograms) content from baseline to day 35 was analyzed using a mixed model repeated. The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a reticulocyte hemoglobin content.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female participants 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.

2. Screening Hgb <11 g/dL.

3. Screening ferritin ≤300 ng/mL and transferrin saturation (TSAT) <30%.

4. Participants must have a documented history of an inadequate response to any oral iron therapy for at least 8 weeks (56 days) prior to randomization.

5. For participants who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for at least 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial.

6. Participants undergoing treatment for inflammatory bowel disease (IBD) must be on stable therapy for at least 8 weeks prior to consent.

Exclusion Criteria:

1. Known history of hypersensitivity reaction to any component of FCM.

2. Previous randomization and treatment in this study or any other clinical study of FCM or VIT-45.

3. History of acquired iron overload, hemochromatosis, or other iron accumulation disorders.

4. Chronic kidney disease participants on hemodialysis.

5. History of significant diseases of the liver, hematopoietic system, cardiovascular system, psychiatric disorder, or other conditions which, on the opinion of the investigator, may place a subject at added risk for participation in the study.

6. Any existing non-viral infection.

7. Known history of positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.

8. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).

9. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin B12 or folic acid deficiency) that has not been corrected.

10. Intravenous iron and /or blood transfusion in the 4 weeks prior to consent.

11. Administration and / or use of an investigational product (drug or device) within 30 days of screening.

12. Alcohol or drug abuse within the past six months.

13. Female participant who is pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.

14. Unable to comply with study procedures and assessments

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arkansas Children's Hospital	Little Rock	Arkansas	United States	72202
2	International Research Partners, Inc.	Doral	Florida	United States	33122
3	ProHealth Research Center	Doral	Florida	United States	33166
4	South Florida Research Phase I-IV	Miami Springs	Florida	United States	33166
5	Garden Medical Research, Inc.	Miami	Florida	United States	33155
6	Miami Clinical Research	Miami	Florida	United States	33155
7	Riley Hospital for Children,Room 4340	Indianapolis	Indiana	United States	46202
8	Caro Health Plaza	Caro	Michigan	United States	48723
9	Galen Research	Chesterfield	Missouri	United States	63005
10	Tiga Pediatrics, PC	Bronx	New York	United States	10467
11	Cincinnati Children's Hospital and Medical Center	Cincinnati	Ohio	United States	45229
12	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
13	Cook Children's Medical Center	Fort Worth	Texas	United States	76101
14	Baylor College of Medicine/Texas Children Hospital	Houston	Texas	United States	77030
15	Tekton Research	San Antonio	Texas	United States	78240
16	Aspen Clinical Research	Orem	Utah	United States	84058

Sponsors and Collaborators

• American Regent, Inc.

Investigators

• Study Director: Mark Falone, American Regent, Inc.

Study Documents (Full-Text)

• Study Protocol - Sep 26, 2019
• Statistical Analysis Plan - Sep 26, 2019

More Information

Publications

None provided.

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT03523117
• Other Study ID Numbers: 1VIT17044
• First Posted: May 14, 2018
• Last Update Posted: Jun 22, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia; Anemia, Iron-Deficiency

Study Results

Participant Flow

Pre-assignment Detail

Phase 3, multicenter, multinational, randomized, active-controlled study that compared the efficacy and safety of FCM to oral iron in pediatric participants with IDA and a documented history of an inadequate response to oral iron at least 8 weeks (56 days) prior to randomization. Participants who satisfied the inclusion requirements and no exclusionary criteria were eligible to participate in this study and enter into a screening phase to confirm eligibility.

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
Period Title: Overall Study
STARTED	40	39
COMPLETED	39	37
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate	Total
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy	Total of all reporting groups
Overall Participants	40	39	79
Age, Customized (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.5 (.5)	12.8 (.4)	12.6 (.5)
Sex: Female, Male (Count of Participants)
Female	33 82.5%	30 76.9%	63 79.7%
Male	7 17.5%	9 23.1%	16 20.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 2.6%	1 1.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	5 12.5%	4 10.3%	9 11.4%
White	35 87.5%	34 87.2%	69 87.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change in Hemoglobin g/dL
Description	Change in hemoglobin g/dL from baseline to day 35 will be analyzed using parametric analysis of covariance (ANCOVA). The model will include terms for the randomization strata (hemoglobin and age categories), baseline hemoglobin, as well as treatment group. Baseline hemoglobin will be defined as the last hemoglobin obtained before randomization.
Time Frame	Baseline to day 35

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT)

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
Measure Participants	40	39
Least Squares Mean (95% Confidence Interval) [g/dL]	2.22	1.92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferric Caroboxymaltose, Oral Ferrous Sulfate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.3108
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Ferritin µg/L From Baseline to Day 35
Description	Change in ferritin µg/L from baseline to day 35 was analyzed using parametric analysis of covariance (ANCOVA). The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a covariate.
Time Frame	Baseline to day 35

Outcome Measure Data

Analysis Population Description

intent to treat (ITT) all randomized

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
Measure Participants	40	39
Least Squares Mean (95% Confidence Interval) [µg/L]	2.22	1.92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferric Caroboxymaltose, Oral Ferrous Sulfate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Change in TSAT (%) From Baseline to Day 35
Description	Change in TSAT (%) from baseline to day 35 was analyzed using parametric analysis of covariance (ANCOVA). The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a covariate
Time Frame	Baseline to day 35

Outcome Measure Data

Analysis Population Description

Intent to treatment

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
Measure Participants	40	39
Least Squares Mean (95% Confidence Interval) [percentage]	24.30	8.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferric Caroboxymaltose, Oral Ferrous Sulfate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	15.64
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Change in Reticulocyte Hemoglobin (Picograms) Content From Baseline to Day 35
Description	Change in reticulocyte hemoglobin (picograms) content from baseline to day 35 was analyzed using a mixed model repeated. The model included terms for the randomization strata (hemoglobin and age categories), baseline ferritin as a reticulocyte hemoglobin content.
Time Frame	Baseline to day 35

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Ferric Caroboxymaltose	Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron	Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
Measure Participants	40	39
Least Squares Mean (95% Confidence Interval) [picograms]	6.95	4.90

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ferric Caroboxymaltose, Oral Ferrous Sulfate
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.06
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Day 1 through Day 35
Adverse Event Reporting Description	AE will be elicited by nonspecific questions such as "Have you noticed any problems?" Participants will be encouraged to report AEs at their onset. Any AE spontaneously reported by, elicited from the participant, or observed by the physician or study staff, shall be recorded on the appropriate Adverse Event (AE) page of the eCRF. T
Arm/Group Title	Ferric Caroboxymaltose		Oral Ferrous Sulfate
Arm/Group Description	Ferric Carboxymaltose - 2 doses (day 0 and day 7) at 15 mg/kg to a maximum single dose of 750 mg (whichever is smaller) up to a maximum of total dose of 1500 mg administered as either an undiluted IV push at a rate of 100 mg (2mL)/minute OR in no more than 250 mL of normal saline and infused over 15 minutes. Ferric carboxymaltose: Intravenous iron		Oral Ferrous Sulfate - will receive an age-dependent formulation of oral ferrous sulfate daily for 28 days as follows: participants <12 years of age will receive 6 mg (elemental iron)/kg/day divided into 2 daily doses of an oral liquid formulation, either drops or elixir, and participants ≥12 will receive 2 daily doses of oral tablets. Infants and children (ages 1 to <4 years) will receive oral ferrous sulfate drops, while children (ages ≥4 to <12 years) will receive oral ferrous sulfate elixir. Adolescents (ages ≥12 to 17 years) will receive an oral ferrous sulfate tablet (65 mg of elemental iron/tablet/dose) twice a day (BID). The maximum daily dose for all participants is 130 mg of elemental iron. Ferrous Sulfate: oral iron therapy
All Cause Mortality
	Ferric Caroboxymaltose		Oral Ferrous Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)
Serious Adverse Events
	Ferric Caroboxymaltose		Oral Ferrous Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Ferric Caroboxymaltose		Oral Ferrous Sulfate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.