Trial Outcomes & Findings for Darbepoetin Alfa With or Without Intravenous (IV) Iron (NCT NCT00401544)

NCT ID: NCT00401544

Last Updated: 2014-01-29

Results Overview

Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 243 participants
• Primary outcome timeframe: From Week 1 to Week 16
• Results posted on: 2014-01-29

Participant Flow

Participants were enrolled from 18 December 2006 through 27 August 2007.

A total of 243 patients were randomizd and 238 received study drug (4 participants in the Darbepoetin alfa 300 μg plus Iron group and 1 in the Darbepoetin alfa 500 μg plus Iron group were not treated)

Participant milestones

Measure	Darbepoetin Alfa 300 μg Plus Iron Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 300 μg Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Overall Study STARTED	56	62	60	60
Overall Study COMPLETED	38	44	48	44
Overall Study NOT COMPLETED	18	18	12	16

Reasons for withdrawal

Measure	Darbepoetin Alfa 300 μg Plus Iron Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 300 μg Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Overall Study Adverse Event	5	1	1	1
Overall Study Death	3	6	2	5
Overall Study Lost to Follow-up	2	0	1	1
Overall Study Withdrawal by Subject	7	6	6	5
Overall Study Physician Decision	1	3	0	0
Overall Study Ineligibility determined	0	1	0	2
Overall Study Disease progression	0	1	0	0
Overall Study Other	0	0	2	2

Baseline Characteristics

Darbepoetin Alfa With or Without Intravenous (IV) Iron

Baseline characteristics by cohort

Measure	Darbepoetin Alfa 300 μg Plus Iron n=56 Participants Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 300 μg n=62 Participants Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg n=60 Participants Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron n=60 Participants Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Total n=238 Participants Total of all reporting groups
Age, Continuous	61.2 Years STANDARD_DEVIATION 12.5 • n=5 Participants	62.1 Years STANDARD_DEVIATION 14.1 • n=7 Participants	66.7 Years STANDARD_DEVIATION 12.0 • n=5 Participants	62.3 Years STANDARD_DEVIATION 13.3 • n=4 Participants	63.1 Years STANDARD_DEVIATION 13.1 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	44 Participants n=7 Participants	33 Participants n=5 Participants	47 Participants n=4 Participants	158 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	18 Participants n=7 Participants	27 Participants n=5 Participants	13 Participants n=4 Participants	80 Participants n=21 Participants
Race/Ethnicity, Customized Black or African American	7 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	32 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=5 Participants	7 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized White or Caucasian	45 Participants n=5 Participants	48 Participants n=7 Participants	50 Participants n=5 Participants	46 Participants n=4 Participants	189 Participants n=21 Participants
FACT-Fatigue Score	28.54 Units on a scale STANDARD_DEVIATION 12.32 • n=5 Participants	30.24 Units on a scale STANDARD_DEVIATION 12.46 • n=7 Participants	28.60 Units on a scale STANDARD_DEVIATION 11.95 • n=5 Participants	30.25 Units on a scale STANDARD_DEVIATION 11.79 • n=4 Participants	29.44 Units on a scale STANDARD_DEVIATION 12.08 • n=21 Participants
Hemoglobin	9.4 g/dL STANDARD_DEVIATION 1.1 • n=5 Participants	9.4 g/dL STANDARD_DEVIATION 0.9 • n=7 Participants	9.4 g/dL STANDARD_DEVIATION 1.2 • n=5 Participants	9.2 g/dL STANDARD_DEVIATION 0.9 • n=4 Participants	9.4 g/dL STANDARD_DEVIATION 1.0 • n=21 Participants

PRIMARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.

Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=112 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=115 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants Who Achieved the Target Hemoglobin Level, by Darbepoetin Alfa Dose	71 Participants	82 Participants	—	—

PRIMARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.

Target hemoglobin was defined as ≥ 11 g/dL during the treatment period in the absence of a red blood cell (RBC) transfusion on the day of measurement or during the preceding 28 days.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=117 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=110 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants Who Achieved the Target Hemoglobin Levels, by IV Iron Usage	73 Participants	80 Participants	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.

The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=112 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=115 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Time to Achieve Target Hemoglobin Level, by Darbepoetin Alfa Dose	10.0 Weeks Interval 7.0 to 11.0	8.0 Weeks Interval 6.0 to 10.0	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, who had baseline hemoglobin values \< 11.0 g/dL.

The time to target hemoglobin is the interval in weeks between study day 1 and the first day that a hemoglobin value ≥ 11.0 g/dL is observed during the treatment period. If a participant did not achieve the target hemoglobin by the time of withdrawal or the end of the treatment period (EOTP), the time to target hemoglobin was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using Kaplan-Meier estimates.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=117 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=110 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Time to Achieve the Target Hemoglobin Level, by IV Iron Usage	9.0 Weeks Interval 7.0 to 11.0	8.0 Weeks Interval 5.0 to 10.0	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.

Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=118 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=120 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Change From Baseline in Hemoglobin Concentration, by Darbepoetin Alfa Dose	1.5 g/dL Standard Deviation 1.8	1.6 g/dL Standard Deviation 1.8	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug. Imputation by last value carried forward (LVCF) was applied.

Change in hemoglobin concentration from Baseline to the end of the treatment period (Week 16).

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=122 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=116 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Change From Baseline in Hemoglobin Concentration, by IV Iron Usage	1.3 g/dL Standard Deviation 1.7	1.9 g/dL Standard Deviation 1.8	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.

The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=118 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=120 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by Darbepoetin Alfa Dose	45 Participants	43 Participants	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug.

The number of participants with ≥ 1 red blood cell (RBC) transfusion from week 1 to end of study (EOS). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=122 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=116 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 1 to End of Study, by IV Iron Usage	47 Participants	41 Participants	—	—

SECONDARY outcome

Timeframe: From Week 5 to Week 16

Population: Subset of Primary Analysis Set, composed of all randomized participants who received at least one dose of blinded study medication, and who were eligible for an RBC transfusion at week 5.

Number of participants with ≥ 1 RBC transfusion from Week 5 to end of study (Week 16)). Participants with a hemoglobin value ≤ 8 g/dL but no RBC transfusion were counted as having had a transfusion.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=56 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=60 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron n=59 Participants Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg n=57 Participants Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants With ≥ 1 Red Blood Cell Transfusion From Week 5 to End of Study	14 Participants	17 Participants	18 Participants	15 Participants

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.

Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=118 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=120 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants With a Hematopoietic Response, by Darbepoetin Alfa Dose	70 Participants	81 Participants	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.

Number of participants with a hematopoietic response, defined as > 2 g/dL increase from baseline or hemoglobin ≥ 12 g/dL during the treatment period in the absence of a red blood cell transfusion within the prior 28 days. Assessing the effect of iron in a factorial experiment.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=122 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=116 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Number of Participants With a Hematopoietic Response, by IV Iron Usage	65 Participants	86 Participants	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.

The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=118 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=120 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Time to Hematopoietic Response, by Darbepoetin Alfa Dose	11.0 Weeks Interval 8.0 to 12.0	9.0 Weeks Interval 8.0 to 10.0	—	—

SECONDARY outcome

Timeframe: From Week 1 to Week 16

Population: Subset of Primary Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, who had a baseline hemoglobin value.

The time to hematopoietic response is the interval in weeks between study day 1 and the first day that a hematopoietic response is observed during the treatment period. Hematopoietic response is defined as an increase in hemoglobin concentration of ≥ 2.0 g/dL from baseline or a hemoglobin concentration ≥ 12.0 g/dL in the absence of RBC transfusions on the day of measurement and during the preceding 28 days of the treatment period. If a participant did not achieve a hematopoietic response by the time of withdrawal or the end of the treatment period (EOTP), the time to hematopoietic response was censored on the day of the last hemoglobin measurement or the EOTP, whichever was earlier. Median was calculated using using Kaplan-Meier estimates.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=122 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=116 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Time to Hematopoietic Response, by IV Iron Usage	12.0 Weeks Interval 10.0 to 15.0	8.0 Weeks Interval 7.0 to 9.0	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.

Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=114 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=114 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by Darbepoetin Alfa Dose	3.1 Units on a scale Standard Deviation 11.8	0.6 Units on a scale Standard Deviation 12.5	—	—

SECONDARY outcome

Timeframe: Baseline and Week 16

Population: Patient-Reported Outcomes (PRO) Analysis Set, composed of all participants who were randomized, properly consented, and received at least one dose of blinded study drug, and who completed at least one baseline and one post-baseline PRO assessment.

Health related quality of life was measured using the Functional Assessment of Cancer Therapy (FACT) - Fatigue subscale. The FACT-F includes 13 fatigue items, with each item assessed on a 5-point scale (ie, response values of 0 to 4). The FACT-F subscale score ranges from 0 to 52, where a higher score represents less fatigue.

Outcome measures

Measure	Combined Darbepoetin Alfa 300 μg n=115 Participants Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Combined Darbepoetin Alfa 500 μg n=113 Participants Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Plus Iron Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 μg Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Change From Baseline in Functional Assessment of Cancer Therapy (FACT) - Fatigue Score, by IV Iron Usage	1.0 Units on a scale Standard Deviation 13.1	2.7 Units on a scale Standard Deviation 11.2	—	—

Adverse Events

Darbepoetin Alfa 300 µg (Without IV Iron)

Serious events: 26 serious events

Other events: 48 other events

Deaths: 0 deaths

Darbepoetin Alfa 300 µg Plus Iron

Serious events: 18 serious events

Other events: 46 other events

Deaths: 0 deaths

Darbepoetin Alfa 500 µg (Without Iron)

Serious events: 19 serious events

Other events: 51 other events

Deaths: 0 deaths

Darbepoetin Alfa 500 µg Plus Iron

Serious events: 23 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	Darbepoetin Alfa 300 µg (Without IV Iron) n=61 participants at risk Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 300 µg Plus Iron n=57 participants at risk Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 µg (Without Iron) n=60 participants at risk Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 µg Plus Iron n=60 participants at risk Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Blood and lymphatic system disorders Anaemia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Bone marrow failure	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Febrile neutropenia	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Neutropenia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Pancytopenia	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Acute myocardial infarction	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Angina pectoris	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Atrial fibrillation	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Atrial flutter	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Atrioventricular block complete	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Cardiac arrest	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Cardiac failure congestive	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Cardio-respiratory arrest	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Cardiogenic shock	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Myocardial infarction	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Tachycardia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Ventricular arrhythmia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Cardiac disorders Ventricular fibrillation	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Abdominal pain	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Ascites	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Constipation	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Diarrhoea	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Dysphagia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Enlarged uvula	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Gastritis	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Haematemesis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Intestinal stenosis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Lip swelling	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Nausea	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Oesophageal stenosis	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Vomiting	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Asthenia	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Chest pain	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Chills	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Disease progression	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Fatigue	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Malaise	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Non-cardiac chest pain	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Oedema peripheral	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Pain	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Pyrexia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Hepatobiliary disorders Hyperbilirubinaemia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Immune system disorders Anaphylactic reaction	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Bacteraemia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Bronchitis	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Catheter related infection	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Clostridium difficile colitis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Gastroenteritis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Infection	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Intervertebral discitis	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Lobar pneumonia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Pneumonia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Sepsis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Urinary tract infection	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Urosepsis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Injury, poisoning and procedural complications Drug toxicity	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Investigations Blood potassium decreased	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Dehydration	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Hypokalaemia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Hyponatraemia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Arthralgia	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Back pain	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Altered state of consciousness	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Cerebral ischaemia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Convulsion	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Headache	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Syncope	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Psychiatric disorders Mental status changes	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Haematuria	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Hydronephrosis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Nephropathy	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Renal failure	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Renal failure acute	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Renal and urinary disorders Ureteric obstruction	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Reproductive system and breast disorders Uterine enlargement	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Bronchial obstruction	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Vascular disorders Deep vein thrombosis	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Vascular disorders Femoral arterial stenosis	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Vascular disorders Hypertension	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Vascular disorders Hypotension	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.

Other adverse events

Measure	Darbepoetin Alfa 300 µg (Without IV Iron) n=61 participants at risk Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 300 µg Plus Iron n=57 participants at risk Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 µg (Without Iron) n=60 participants at risk Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).	Darbepoetin Alfa 500 µg Plus Iron n=60 participants at risk Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
Blood and lymphatic system disorders Anaemia	19.7% 12/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	21.1% 12/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	23.3% 14/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Leukopenia	14.8% 9/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	12.3% 7/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Neutropenia	14.8% 9/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Blood and lymphatic system disorders Thrombocytopenia	14.8% 9/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	19.3% 11/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	11.7% 7/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Abdominal pain	11.5% 7/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Abdominal pain upper	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Constipation	9.8% 6/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	7.0% 4/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Diarrhoea	14.8% 9/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.5% 6/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	18.3% 11/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Dry mouth	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Dyspepsia	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Dysphagia	8.2% 5/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Nausea	21.3% 13/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	16.7% 10/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	18.3% 11/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Gastrointestinal disorders Vomiting	16.4% 10/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Asthenia	9.8% 6/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.5% 6/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Disease progression	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Fatigue	44.3% 27/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	29.8% 17/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	33.3% 20/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	31.7% 19/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Mucosal inflammation	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Oedema peripheral	14.8% 9/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	7.0% 4/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	11.7% 7/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Pain	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	13.3% 8/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
General disorders Pyrexia	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Infections and infestations Urinary tract infection	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Investigations Weight decreased	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Anorexia	11.5% 7/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.5% 6/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.0% 9/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Decreased appetite	11.5% 7/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Metabolism and nutrition disorders Dehydration	8.2% 5/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	7.0% 4/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Arthralgia	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Bone pain	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Muscular weakness	4.9% 3/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Dizziness	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	11.7% 7/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	11.7% 7/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Nervous system disorders Neuropathy	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Psychiatric disorders Insomnia	9.8% 6/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.8% 5/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Cough	3.3% 2/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	15.8% 9/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	13.3% 8/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.4% 10/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	21.1% 12/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	10.0% 6/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	6.7% 4/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.8% 1/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Respiratory, thoracic and mediastinal disorders Wheezing	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.3% 3/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Skin and subcutaneous tissue disorders Alopecia	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	5.0% 3/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	8.3% 5/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	0.00% 0/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Skin and subcutaneous tissue disorders Rash	1.6% 1/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	7.0% 4/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	1.7% 1/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.
Vascular disorders Hypotension	6.6% 4/61 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.5% 2/57 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.	3.3% 2/60 • From first dose date to 3 weeks after the last dose of study drug or IV iron (Week 16). The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events. One patient who was randomized to the 300 μg without iron arm received commercial iron product and was counted in the 300 μg with iron arm.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

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