IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Study to Investigate the Efficacy and Safety of Injectafer®

• Sponsor: American Regent, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02453334
• Collaborator: (none)
• Enrollment: 244
• Locations: 29
• Arms: 2
• Actual Duration (Months): 31.4
• Patients Per Site: 8.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study.

Condition or Disease	Intervention/Treatment	Phase
Cancer and Chemotherapy Related Anemia	Drug: Injectafer; Other: Normal Saline	Phase 3

Detailed Description

This is a Phase III, multicenter, randomized, double-blinded, prospective study with two parallel treatment groups. Patients who present to the hematologist/oncologist and satisfy all inclusion and exclusion criteria will be eligible for participation in this 18-week study. Subjects who meet all inclusion criteria and no exclusion criteria, will be randomized into the trial (Group A or B).

Study Design

• Study Type: Interventional
• Actual Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: IRON CLAD: Can Iron Lessen Anemia Due to Cancer and Chemotherapy: A Multi-center, Randomized, Double-blinded, Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose Injection) in Adults
• Actual Study Start Date: May 23, 2015
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Injectafer 2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg.	Drug: Injectafer; Other Names: ferric carboxymaltose injection
Placebo Comparator: Normal Saline Normal saline administered as an infusion of no more than 250mL infused over 15 minutes.	Other: Normal Saline

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18 [Week 3 to Week 18]

   The following participants will be considered to have met the primary endpoint: Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. Participants who have a non-study intervention prior to Week 18. Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.

Secondary Outcome Measures

1. Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention [Baseline to Week 18]

   Nonstudy Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron

2. Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention [Baseline to Week 18]

   Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.

3. Percentage of Participants Who Received Nonstudy Intervention [Baseline to week 18]

   Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron

4. Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention [Baseline to week 18]

   Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron

5. Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention [Baseline to Week 18]

   Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively

6. Percentage of Participants Requiring a Blood Transfusion [Baseline to week 18]

   Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.

7. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Day 7]

   Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

8. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Week 2]

   Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

9. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Week 3]

   Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

10. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Week 6]

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

11. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Week 9]

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

12. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. [Baseline to Week 12]

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

13. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit. [Baseline to Week 15]

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

14. Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit [Baseline to Week 18]

    Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.

15. Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 [Baseline to Week 18]

    Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.

16. Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18 [From Baseline to Week 18]

    Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.

17. Correlation of Change in Hemoglobin With Baseline Hepcidin Level [Baseline to Week 18.]

    For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.

18. Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18 [Baseline to Week 18]

    Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects (male of female) ≥ 18 years of age able to give informed consent to the study.

• Subjects with non-myeloid malignancies

• Receiving chemotherapy as part of their cancer treatment with at least 4 weeks of treatment remaining.

• Screening visit central laboratory hemoglobin (Hgb) ≤11 g/dL, but ≥8 g/dL.

• Ferritin between 100 and 800 ng/mL and transferrin saturation (TSAT) =<35%

• Subjects must have Eastern Coopertative Oncology Group (ECOG) performance status of 0-2.

• Life expectancy of at least 6 months.

• Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments.

Exclusion Criteria:

• Previous participation in a ferric carboxymaltose clinical trial.

• Known hypersensitivity reaction to any component of ferric carboxymaltose.

• Subjects with overt bleeding

• Any anemia treatment within 4 weeks before inclusion (oral iron, IV iron, transfusion, or erythropoiesis-stimulating agents).

• Subjects on erythropoiesis-stimulating agents.

• Requiring dialysis for the treatment of chronic kidney disease.

• Any non-viral infection.

• Known positive hepatitis with evidence of active disease.

• Received an investigational drug within 30 days of screening.

• Alcohol or drug abuse within the past 6 months.

• Hemochromatosis or other iron storage disorders.

• Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the Investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.

• Pregnant or actively trying to become pregnant (Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Compassionate Care Research Group, Inc.	Corona	California	United States	92879
2	Compassionate Care Research Group, Inc.	Fountain Valley	California	United States	92708
3	Compassionate Care Research Group, Inc.	Riverside	California	United States	92501
4	University Cancer Institute	Boynton Beach	Florida	United States	33426
5	AR Development Solutions	Miami Lakes	Florida	United States	33014
6	Lakes Research	Miami Lakes	Florida	United States	33014
7	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33606
8	Bond Bond Clinic, P.A.	Winter Haven	Florida	United States	33880
9	Joliet Oncology Hematology Associates	Joliet	Illinois	United States	60435
10	MId-Illinois Hematology & Oncology Associates, Ltd.	Normal	Illinois	United States	61761
11	OSF Saint Anthony Medical Center for Cancer Care	Rockford	Illinois	United States	61108
12	Horizon Oncology Research, Inc.	Lafayette	Indiana	United States	47905
13	Michiana Hematology Oncology, PC	South Bend	Indiana	United States	46628
14	Northern Indiana Cancer Research Consortium	South Bend	Indiana	United States	46628
15	Ashland-Bellefonte Cancer Center	Ashland	Kentucky	United States	41101
16	Rcca Md, Llc	Bethesda	Maryland	United States	20817
17	Antietam Oncology and Hematology Group, P.C.	Hagerstown	Maryland	United States	21740
18	North Mississippi and Oncology Associates	Tupelo	Mississippi	United States	38801
19	Montefiore Medical Center	Bronx	New York	United States	10467
20	East Chester Cancer Center	Bronx	New York	United States	10469
21	The Brookdale University Hospital and Medical Center	Brooklyn	New York	United States	11212
22	Richmond University Medical Center	Staten Island	New York	United States	10310
23	Waverly Hematology Oncology	Cary	North Carolina	United States	27518
24	Kinston Medical Specialists	Kinston	North Carolina	United States	28501
25	Gettysburg Cancer Center	Gettysburg	Pennsylvania	United States	17325
26	Charleston Hematology/Oncology Associates, P.A.	Charleston	South Carolina	United States	29414
27	Carolina Blood and Cancer Care, PA	Rock Hill	South Carolina	United States	29732
28	Westchase Clinical Associates	Houston	Texas	United States	77042
29	Bon Secours St. Francis Medical Center	Midlothian	Virginia	United States	23114

Sponsors and Collaborators

• American Regent, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 2, 2017
• Statistical Analysis Plan - Jan 3, 2018

More Information

Publications

None provided.

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT02453334
• Other Study ID Numbers: 1VIT14039
• First Posted: May 25, 2015
• Last Update Posted: May 11, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Anemia

Study Results

Participant Flow

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Period Title: Overall Study
STARTED	122	122
COMPLETED	81	82
NOT COMPLETED	41	40

Baseline Characteristics

Arm/Group Title	Injectafer	Normal Saline	Total
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline	Total of all reporting groups
Overall Participants	122	122	244
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.0 (10.02)	63.1 (9.26)	63.0 (9.63)
Sex: Female, Male (Count of Participants)
Female	67 54.9%	69 56.6%	136 55.7%
Male	55 45.1%	53 43.4%	108 44.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 2.5%	7 5.7%	10 4.1%
Not Hispanic or Latino	119 97.5%	115 94.3%	234 95.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White	117 95.9%	112 91.8%	229 93.9%
Black/African-American	5 4.1%	8 6.6%	13 5.3%
Multiple	0 0%	2 1.6%	2 0.8%
American Indian/Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian/Other Pacific Islander	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	22 18%	22 18%	44 18%
Georgia	39 32%	38 31.1%	77 31.6%
Hungary	26 21.3%	27 22.1%	53 21.7%
Poland	24 19.7%	24 19.7%	48 19.7%
Bulgaria	11 9%	11 9%	22 9%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	166.9 (9.5)	165.9 (9.6)	166.4 (9.5)
Iron intolerance (Count of Participants)
Yes	3 2.5%	3 2.5%	6 2.5%
No	119 97.5%	119 97.5%	238 97.5%
ECOG grade (Count of Participants)
0	39 32%	30 24.6%	69 28.3%
1	75 61.5%	83 68%	158 64.8%
2	8 6.6%	9 7.4%	17 7%
3	0 0%	0 0%	0 0%
4	0 0%	0 0%	0 0%
Cancer stage (Count of Participants)
0	2 1.6%	0 0%	2 0.8%
1	0 0%	0 0%	0 0%
2	2 1.6%	7 5.7%	9 3.7%
3	9 7.4%	12 9.8%	21 8.6%
4	81 66.4%	69 56.6%	150 61.5%
Unknown	28 23%	34 27.9%	62 25.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Week 3 to Week 18
Description	The following participants will be considered to have met the primary endpoint: Participants with observed Hgb decrease from baseline between 0.5 g/dL to 1.0 g/dL on two consecutive visits between Weeks 3 and 18. Participants with observed Hgb decrease from baseline ≥1.0 g/dL at one visit. Participants who have a non-study intervention prior to Week 18. Participants who discontinue prior to Week 18 for lack of efficacy or adverse events.
Time Frame	Week 3 to Week 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	121	118
Count of Participants [Participants]	42 34.4%	60 49.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0143
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.30 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-15.6
	Confidence Interval	(2-Sided) 95%; -28.01 to -3.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Hemoglobin From Baseline to Week 18 or to Nonstudy Intervention
Description	Nonstudy Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Baseline	9.63 (1.000)	9.75 (1.008)
Day 7 Change from Baseline	0.27 (0.901)	0.01 (0.741)
Week 2 Change from Baseline	0.53 (1.077)	0.06 (0.937)
Week 3 Change from Baseline	0.58 (1.015)	0.04 (1.028)
Week 6 Change from Baseline	0.84 (1.264)	0.07 (1.254)
Week 9 Change from Baseline	0.85 (1.174)	0.37 (1.512)
Week 12 Change from Baseline	1.00 (1.202)	0.74 (1.274)
Week 15 Change from Baseline	0.97 (1.394)	0.79 (1.313)
Week 18/ET Change from Baseline	1.04 (1.718)	0.87 (1.475)

3. Secondary Outcome

Title	Percentage of Participants With Hemoglobin Increase From Baseline ≥ 1 g/dL at Any Postbaseline Visits Without Receiving a Nonstudy Intervention
Description	Summary of number and percentage(%) of participants with Hgb increase ≥ 1 g/dL increase at any time point in the absence of non-study intervention.
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Count of Participants [Participants]	84 68.9%	64 52.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0097
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.04
	Confidence Interval	(2-Sided) 95%; 1.19 to 3.50
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments	Percentage difference
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	16.4
	Confidence Interval	(2-Sided) 95%; 4.19 to 28.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Who Received Nonstudy Intervention
Description	Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron
Time Frame	Baseline to week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Count of Participants [Participants]	22 18%	25 20.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-2.7
	Confidence Interval	(2-Sided) 95%; -12.85 to 7.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments	Placebo group was used as the denominator for odds ratio calculation.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5758
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.43 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With Hemoglobin > 12 g/dL in the Absence of Non-study Intervention
Description	Intervention is defined as any of the following: Initiation of erythropoietin for any reason Blood transfusion IV iron Prescribed use of oral iron
Time Frame	Baseline to week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Count of Participants [Participants]	31 25.4%	24 19.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2772
	Comments	Placebo group was used as the denominator for odds ratio calculation
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.40
	Confidence Interval	(2-Sided) 95%; 0.76 to 2.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	5.7
	Confidence Interval	(2-Sided) 95%; -5.01 to 16.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Time to Hemoglobin Increase ≥ 1 g/dL in the Absence of Non-study Intervention
Description	Participants who discontinued or completed the study, or received a non-study intervention before having an increased in Hgb ≥ 1 g/dL will be censored at last study visit or time of receiving non-study intervention, respectively
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Q1, 1st quartile	15	23
Q2, 2nd quartile or median	43	85
Q3, 3rd quartile	106	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0011
	Comments
	Method	Log Rank
	Comments	P-value was estimated using logrank test stratified by country

7. Secondary Outcome

Title	Percentage of Participants Requiring a Blood Transfusion
Description	Summary of the number (percentage) of participants requiring a blood transfusion at any time during the trial.
Time Frame	Baseline to week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Count of Participants [Participants]	15 12.3%	14 11.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -7.60 to 9.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8924
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.05
	Confidence Interval	(2-Sided) 95%; 0.49 to 2.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Day 7

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Day 7 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	112	112
Count of Participants [Participants]	18 14.8%	29 23.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-9.8
	Confidence Interval	(2-Sided) 95%; -20.41 to 0.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country. Placebo group was used as the denominator for odds ratio calculation.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0740
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	Placebo group was used as the denominator for odds ratio calculation.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; 0.28 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 2

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 2 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	107	100
Count of Participants [Participants]	17 13.9%	28 23%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-12.1
	Confidence Interval	(2-Sided) 95%; -23.31 to -0.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0446
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
	Method	Cochran-Mantel-Haenszel
	Comments	Placebo group was used as the denominator for odds ratio calculation
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.51
	Confidence Interval	(2-Sided) 95%; 0.26 to 0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 3

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 3 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	98	103
Count of Participants [Participants]	12 9.8%	33 27%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-19.8
	Confidence Interval	(2-Sided) 95%; -30.90 to -8.69
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0010
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
	Method	Cochran-Mantel-Haenszel
	Comments	Placebo group was used as the denominator for odds ratio calculation.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.30
	Confidence Interval	(2-Sided) 95%; 0.14 to 0.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 6

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 6 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	92	93
Count of Participants [Participants]	12 9.8%	32 26.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-21.4
	Confidence Interval	(2-Sided) 95%; -33.22 to -9.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0009
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.29
	Confidence Interval	(2-Sided) 95%; 0.13 to 0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo group was used as the denominator for odds ratio calculation.

12. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 9

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 9 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	85	79
Count of Participants [Participants]	9 7.4%	21 17.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-16.0
	Confidence Interval	(2-Sided) 95%; -27.73 to -4.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0093
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	(2-Sided) 95%; 0.14 to 0.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo group was used as the denominator for odds ratio calculation.

13. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 12

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 12 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	76	67
Count of Participants [Participants]	8 6.6%	10 8.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-4.4
	Confidence Interval	(2-Sided) 95%; -15.37 to 6.57
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4786
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.70
	Confidence Interval	(2-Sided) 95%; 0.26 to 1.89
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo group was used as the denominator for odds ratio calculation.

14. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit.
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 15

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 15 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	72	65
Count of Participants [Participants]	8 6.6%	12 9.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	-7.4
	Confidence Interval	(2-Sided) 95%; -19.25 to 4.55
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2084
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
	Method	Cochran-Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95%; 0.20 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo group was used as the denominator for odds ratio calculation.

15. Secondary Outcome

Title	Percentage of Participants With a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Each Study Visit
Description	Summary of the number and percentage(%) of participants with Hgb decrease (from baseline) ≥ 0.5 g/dL by visit.
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only participant with both a baseline and at least one post baseline value at Week 18 are included.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	69	63
Count of Participants [Participants]	12 9.8%	9 7.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage difference
	Estimated Value	3.1
	Confidence Interval	(2-Sided) 95%; -9.33 to 15.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6508
	Comments
	Method	Cochran-Mantel-Haenszel
	Comments	The odds ratio (95% [CI) and P-value of treatment effect is based on Cochran-Mantel-Haenszel (CMH) chi-squared test adjusting for country.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.48 to 3.24
	Parameter Dispersion	Type: Value:
	Estimation Comments	Placebo group was used as the denominator for odds ratio calculation.

16. Secondary Outcome

Title	Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Description	Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Q1	15	14
Q2	127	43

17. Secondary Outcome

Title	Time to a Decrease in Hemoglobin ≥ 0.5 g/dL From Baseline to Week 18
Description	Patients who discontinued or completed the study, or received a nonstudy intervention before having an increase in Hgb ≥ 0.5 g/dL were censored at last study visit or time of receiving nonstudy intervention, respectively.
Time Frame	From Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Q1,1st quartile	15	14
2nd quartile or median	127	43
Q3, 3rd quartile	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Injectafer, Normal Saline
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0063
	Comments	P-value was estimated using logrank test stratified by pooled sites.
	Method	Log Rank
	Comments

18. Secondary Outcome

Title	Correlation of Change in Hemoglobin With Baseline Hepcidin Level
Description	For participants who receive non-study intervention or early withdraw from the study, the time of intervention or early withdrawal will be considered as end of study, respectively.
Time Frame	Baseline to Week 18.

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Hepcidin in 1st Tertile	0.88 (1.892)	1.13 (1.203)
hepcidin in 3rd Tertile	1.28 (1.552)	0.02 (1.394)

19. Secondary Outcome

Title	Total Score of the Functional Assessment of Chronic Illness Therapy Fatigue(FACIT-Fatigue) Scale Mean Change From Baseline to Week 18
Description	Summary of the actual value and change from baseline in total score of Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue Scale). Ranges from 0-52 and higher scores mean better Quality of Life (QOL). Data collected after receiving non-study intervention will not be included in the summary.
Time Frame	Baseline to Week 18

Outcome Measure Data

Analysis Population Description

Only subjects who completed the study from the Modified intention to treat (mITT) population.

Arm/Group Title	Injectafer	Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer	Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
Measure Participants	119	118
Baseline	21.8 (9.47)	21.5 (8.64)
Day 7 Change from Baseline	-0.8 (6.78)	-0.7 (6.21)
Week 2 Change from Baseline	-0.3 (7.34)	0.2 (8.13)
Week 3 Change from Baseline	-0.3 (7.75)	-0.6 (7.41)
Week 6 Change from Baseline	-0.2 (9.70)	-0.7 (8.13)
Week 9 Change from Baseline	-0.7 (8.35)	0.3 (8.22)
Week 12 Change from Baseline	-0.1 (9.82)	-0.5 (8.09)
Week 15 Change from Baseline	-0.1 (9.65)	0.8 (9.11)
Week 18 Change from Baseline	-1.5 (8.78)	0.0 (8.92)

Adverse Events

Time Frame	1 year, 7 months
Arm/Group Title	Injectafer		Normal Saline
Arm/Group Description	2 doses of Injectafer at 15mg/kg for a maximum single dose of 750mg given 7 days apart for a total of up to 1500mg. Injectafer		Normal saline administered as an infusion of no more than 250mL infused over 15 minutes. Normal Saline
All Cause Mortality
	Injectafer		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/118 (0%)
Serious Adverse Events
	Injectafer		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	28/121 (23.1%)		22/118 (18.6%)
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders	4/121 (3.3%)	4	3/118 (2.5%)	3
Cardiac disorders
Cardiac Disorders	2/121 (1.7%)	2	3/118 (2.5%)	3
Gastrointestinal disorders
Gastrointestinal Disorders	7/121 (5.8%)	7	0/118 (0%)	0
General disorders
Disease progression	4/121 (3.3%)	4	4/118 (3.4%)	4
Hepatobiliary disorders
Hepatobiliary Disorders	0/121 (0%)	0	3/118 (2.5%)	3
Infections and infestations
Infections And Infestations	4/121 (3.3%)	4	3/118 (2.5%)	3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	6/121 (5%)	6	1/118 (0.8%)	1
Renal and urinary disorders
Renal And Urinary Disorders	3/121 (2.5%)	3	2/118 (1.7%)	2
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	5/121 (4.1%)	5	3/118 (2.5%)	3
Other (Not Including Serious) Adverse Events
	Injectafer		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	96/121 (79.3%)		95/118 (80.5%)
Blood and lymphatic system disorders
Neutropenia	21/121 (17.4%)	21	14/118 (11.9%)	14
Leukopenia	15/121 (12.4%)	15	13/118 (11%)	13
Thrombocytopenia	10/121 (8.3%)	10	10/118 (8.5%)	10
Gastrointestinal disorders
Diarrhoea	15/121 (12.4%)	15	8/118 (6.8%)	8
Nausea	11/121 (9.1%)	11	11/118 (9.3%)	11
Abdominal pain	7/121 (5.8%)	7	3/118 (2.5%)	3
Constipation	7/121 (5.8%)	7	3/118 (2.5%)	3
General disorders
Fatigue	18/121 (14.9%)	18	17/118 (14.4%)	17
Asthenia	10/121 (8.3%)	10	11/118 (9.3%)	11
Pyrexia	6/121 (5%)	6	11/118 (9.3%)	11
Hepatobiliary disorders
Hepatobiliary Disorders	4/121 (3.3%)	4	6/118 (5.1%)	6
Infections and infestations
Infections and Infestations	16/121 (13.2%)	16	14/118 (11.9%)	14
Injury, poisoning and procedural complications
Gamma-glutamyltransferase increased	6/121 (5%)	6	6/118 (5.1%)	6
Investigations
Neutrophil count decreased	8/121 (6.6%)	8	4/118 (3.4%)	4
Platelet count decreased	8/121 (6.6%)	8	5/118 (4.2%)	5
Aspartate aminotransferase increased	6/121 (5%)	6	4/118 (3.4%)	4
Metabolism and nutrition disorders
Hypophosphatemia	19/121 (15.7%)	19	3/118 (2.5%)	3
Decreased appetite	5/121 (4.1%)	5	7/118 (5.9%)	7
Musculoskeletal and connective tissue disorders
Pain in extremity	6/121 (5%)	6	2/118 (1.7%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression	6/121 (5%)	6	2/118 (1.7%)	2
Neoplasm progression	2/121 (1.7%)	2	6/118 (5.1%)	6
Nervous system disorders
Neuropathy peripheral	2/121 (1.7%)	2	10/118 (8.5%)	10
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	11/121 (9.1%)	11	17/118 (14.4%)	17
Skin and subcutaneous tissue disorders
Alopecia	4/121 (3.3%)	4	7/118 (5.9%)	7
Vascular disorders
Vascular Disorders	11/121 (9.1%)	11	8/118 (6.8%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.