Trial Outcomes & Findings for Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (NCT NCT03237065)
NCT ID: NCT03237065
Last Updated: 2020-02-25
Results Overview
Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
122 participants
Primary outcome timeframe
Baseline to day 35
Results posted on
2020-02-25
Participant Flow
A total of 244 subjects were screened and 122 subjects were randomised into the trial.
Participant milestones
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg iron isomaltoside/ferric derisomaltose at the baseline visit.
|
Ferric Carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg).
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
61
|
|
Overall Study
Safety Analysis Set
|
62
|
57
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
Subjects received iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) as a single IV infusion of 1000 mg iron isomaltoside/ferric derisomaltose at the baseline visit.
|
Ferric Carboxymaltose
Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator product in this trial.
The dose of ferric carboxymaltose for the individual subject was 750 mg, infused IV at baseline and on day 7 (cumulative dose: 1500 mg).
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Unable to obtain venous access
|
0
|
1
|
Baseline Characteristics
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Baseline characteristics by cohort
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
111 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 12.9 • n=93 Participants
|
43.1 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
42.6 years
STANDARD_DEVIATION 12.2 • n=27 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
73 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mayan Indian/Black
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Irish/Black
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=93 Participants
|
57 participants
n=4 Participants
|
119 participants
n=27 Participants
|
|
Current smoker
Yes
|
9 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Current smoker
No
|
53 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Iron Deficiency Anaemia (IDA) due to gynaecological blood loss
Yes
|
44 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Iron Deficiency Anaemia (IDA) due to gynaecological blood loss
No
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
S-phosphate level at screening
<3.5 mg/dL
|
35 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
67 Participants
n=27 Participants
|
|
S-phosphate level at screening
≥3.5 mg/dL
|
27 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)
|
5 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Time with hypophosphatemia (i.e. time with s-phosphate level \< 2.0 mg/dL) from baseline up to day 35. The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was \<2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)
|
11 days
Interval 6.0 to 28.0
|
28 days
Interval 15.0 to 61.0
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=58 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=56 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)
|
0 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Absolute \[∆\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
0.19 mg/dL
Standard Deviation 0.57
|
-0.18 mg/dL
Standard Deviation 0.50
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
-0.44 mg/dL
Standard Deviation 0.57
|
-0.89 mg/dL
Standard Deviation 0.74
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
-0.46 mg/dL
Standard Deviation 0.64
|
-1.14 mg/dL
Standard Deviation 0.74
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
-0.09 mg/dL
Standard Deviation 0.66
|
-1.27 mg/dL
Standard Deviation 0.88
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
0.11 mg/dL
Standard Deviation 0.49
|
-0.99 mg/dL
Standard Deviation 0.96
|
|
Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
-0.32 mg/dL
Standard Deviation 0.60
|
-1.47 mg/dL
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Relative \[%\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
6.89 Percentage change from baseline
Standard Deviation 16.02
|
-4.34 Percentage change from baseline
Standard Deviation 15.28
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
-11.99 Percentage change from baseline
Standard Deviation 15.38
|
-25.83 Percentage change from baseline
Standard Deviation 20.54
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
-12.32 Percentage change from baseline
Standard Deviation 18.50
|
-33.36 Percentage change from baseline
Standard Deviation 19.95
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
-8.66 Percentage change from baseline
Standard Deviation 16.27
|
-43.54 Percentage change from baseline
Standard Deviation 22.00
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
-1.23 Percentage change from baseline
Standard Deviation 19.15
|
-37.71 Percentage change from baseline
Standard Deviation 24.87
|
|
Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
3.88 Percentage change from baseline
Standard Deviation 14.19
|
-28.63 Percentage change from baseline
Standard Deviation 28.14
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35. Fractional excretion of phosphate (FEPi) is calculated as (\[phosphate in urine X creatinine in serum\]/\[phosphate in serum X creatinine in urine\]) X 100, and the unit is %.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 1
|
0.54 percentage excreted
Standard Deviation 4.26
|
1.77 percentage excreted
Standard Deviation 5.15
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 7
|
1.33 percentage excreted
Standard Deviation 5.04
|
4.90 percentage excreted
Standard Deviation 6.48
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 8
|
2.29 percentage excreted
Standard Deviation 5.18
|
6.05 percentage excreted
Standard Deviation 5.71
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 14
|
-0.11 percentage excreted
Standard Deviation 4.59
|
8.50 percentage excreted
Standard Deviation 8.95
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 21
|
-0.04 percentage excreted
Standard Deviation 4.18
|
6.42 percentage excreted
Standard Deviation 6.70
|
|
Change From Baseline in Fractional Phosphate Urinary Excretion
Day 35
|
1.07 percentage excreted
Standard Deviation 4.96
|
5.21 percentage excreted
Standard Deviation 7.74
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 1
|
-4.18 pg/mL
Standard Deviation 18.20
|
93.38 pg/mL
Standard Deviation 88.21
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 7
|
16.97 pg/mL
Standard Deviation 45.44
|
33.60 pg/mL
Standard Deviation 57.37
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 8
|
8.09 pg/mL
Standard Deviation 36.06
|
259.16 pg/mL
Standard Deviation 210.82
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 14
|
-5.35 pg/mL
Standard Deviation 24.09
|
74.07 pg/mL
Standard Deviation 90.35
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 21
|
-9.13 pg/mL
Standard Deviation 28.95
|
54.49 pg/mL
Standard Deviation 74.78
|
|
Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35
Day 35
|
-9.17 pg/mL
Standard Deviation 23.87
|
10.52 pg/mL
Standard Deviation 39.94
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-677.38 RU/mL
Standard Deviation 758.35
|
-843.21 RU/mL
Standard Deviation 1756.37
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-692.44 RU/mL
Standard Deviation 800.04
|
-924.44 RU/mL
Standard Deviation 1748.37
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-753.40 RU/mL
Standard Deviation 803.63
|
-853.50 RU/mL
Standard Deviation 1877.89
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-740.37 RU/mL
Standard Deviation 822.35
|
-925.02 RU/mL
Standard Deviation 1783.26
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
-743.99 RU/mL
Standard Deviation 805.24
|
-986.30 RU/mL
Standard Deviation 1815.76
|
|
Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-737.46 RU/mL
Standard Deviation 791.86
|
-943.91 RU/mL
Standard Deviation 1741.96
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-0.39 ng/mL
Standard Deviation 1.86
|
-0.25 ng/mL
Standard Deviation 2.50
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-0.39 ng/mL
Standard Deviation 3.17
|
0.61 ng/mL
Standard Deviation 3.30
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-0.92 ng/mL
Standard Deviation 3.51
|
0.83 ng/mL
Standard Deviation 3.56
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-1.46 ng/mL
Standard Deviation 4.11
|
0.67 ng/mL
Standard Deviation 3.83
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
-1.23 ng/mL
Standard Deviation 4.65
|
0.13 ng/mL
Standard Deviation 4.11
|
|
Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-0.43 ng/mL
Standard Deviation 6.10
|
-0.66 ng/mL
Standard Deviation 4.60
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
5.89 pg/mL
Standard Deviation 10.60
|
-16.97 pg/mL
Standard Deviation 13.29
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-16.78 pg/mL
Standard Deviation 17.81
|
-23.92 pg/mL
Standard Deviation 30.68
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-12.93 pg/mL
Standard Deviation 17.81
|
-35.59 pg/mL
Standard Deviation 26.05
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-0.40 pg/mL
Standard Deviation 16.54
|
-36.14 pg/mL
Standard Deviation 26.40
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.33 pg/mL
Standard Deviation 16.11
|
-24.02 pg/mL
Standard Deviation 29.00
|
|
Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.05 pg/mL
Standard Deviation 15.33
|
-12.67 pg/mL
Standard Deviation 25.01
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
0.02 ng/mL
Standard Deviation 0.45
|
0.07 ng/mL
Standard Deviation 0.32
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.31 ng/mL
Standard Deviation 0.84
|
0.26 ng/mL
Standard Deviation 0.49
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.22 ng/mL
Standard Deviation 0.84
|
0.38 ng/mL
Standard Deviation 0.46
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
0.10 ng/mL
Standard Deviation 0.75
|
0.55 ng/mL
Standard Deviation 0.68
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.01 ng/mL
Standard Deviation 0.55
|
0.50 ng/mL
Standard Deviation 0.76
|
|
Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.00 ng/mL
Standard Deviation 0.77
|
0.23 ng/mL
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-0.07 pg/mL
Standard Deviation 18.93
|
-7.02 pg/mL
Standard Deviation 25.83
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
-1.72 pg/mL
Standard Deviation 24.41
|
0.73 pg/mL
Standard Deviation 29.37
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
-0.17 pg/mL
Standard Deviation 21.03
|
-3.26 pg/mL
Standard Deviation 27.12
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
7.39 pg/mL
Standard Deviation 24.17
|
22.22 pg/mL
Standard Deviation 31.14
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.67 pg/mL
Standard Deviation 19.36
|
22.80 pg/mL
Standard Deviation 38.82
|
|
Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
-1.58 pg/mL
Standard Deviation 22.86
|
22.19 pg/mL
Standard Deviation 33.21
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product
Safety Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
-0.002 mg/dL
Standard Deviation 0.198
|
0.047 mg/dL
Standard Deviation 0.168
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.020 mg/dL
Standard Deviation 0.206
|
-0.003 mg/dL
Standard Deviation 0.219
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
0.016 mg/dL
Standard Deviation 0.206
|
-0.016 mg/dL
Standard Deviation 0.186
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
-0.090 mg/dL
Standard Deviation 0.500
|
-0.054 mg/dL
Standard Deviation 0.251
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
0.030 mg/dL
Standard Deviation 0.204
|
-0.016 mg/dL
Standard Deviation 0.194
|
|
Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
0.012 mg/dL
Standard Deviation 0.212
|
-0.015 mg/dL
Standard Deviation 0.211
|
SECONDARY outcome
Timeframe: Baseline to day 35Population: Safety analysis set: included all subjects who received at least one dose of the investigational product.
Safety For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=61 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
0.21 g/dL per g of iron
Standard Deviation 0.80
|
0.46 g/dL per g of iron
Standard Deviation 1.10
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
0.99 g/dL per g of iron
Standard Deviation 1.13
|
1.41 g/dL per g of iron
Standard Deviation 1.16
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
1.08 g/dL per g of iron
Standard Deviation 1.21
|
0.84 g/dL per g of iron
Standard Deviation 0.68
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
1.68 g/dL per g of iron
Standard Deviation 1.13
|
1.30 g/dL per g of iron
Standard Deviation 0.85
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
1.82 g/dL per g of iron
Standard Deviation 0.97
|
1.63 g/dL per g of iron
Standard Deviation 0.87
|
|
Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
2.21 g/dL per g of iron
Standard Deviation 1.21
|
2.00 g/dL per g of iron
Standard Deviation 0.90
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=61 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
72.47 ng/mL
Standard Deviation 81.88
|
76.96 ng/mL
Standard Deviation 79.11
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
252.39 ng/mL
Standard Deviation 163.85
|
279.15 ng/mL
Standard Deviation 215.17
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
219.36 ng/mL
Standard Deviation 148.84
|
313.44 ng/mL
Standard Deviation 229.39
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
144.39 ng/mL
Standard Deviation 100.06
|
379.42 ng/mL
Standard Deviation 282.26
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
98.81 ng/mL
Standard Deviation 92.42
|
232.59 ng/mL
Standard Deviation 212.77
|
|
Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
56.27 ng/mL
Standard Deviation 70.64
|
126.20 ng/mL
Standard Deviation 157.49
|
SECONDARY outcome
Timeframe: Baseline, days 1, 7, 8, 14, 21, and 35Population: Intention-To-Treat (ITT) analysis set: included all randomised subjects.
Efficacy Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35. TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=61 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=61 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 1
|
121.77 percentage of saturation
Standard Deviation 53.11
|
83.78 percentage of saturation
Standard Deviation 42.38
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 7
|
15.05 percentage of saturation
Standard Deviation 10.00
|
12.92 percentage of saturation
Standard Deviation 28.49
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 8
|
12.27 percentage of saturation
Standard Deviation 9.59
|
73.44 percentage of saturation
Standard Deviation 34.31
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 14
|
10.34 percentage of saturation
Standard Deviation 7.68
|
16.74 percentage of saturation
Standard Deviation 12.61
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 21
|
10.61 percentage of saturation
Standard Deviation 9.81
|
16.19 percentage of saturation
Standard Deviation 10.59
|
|
Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35
Day 35
|
9.87 percentage of saturation
Standard Deviation 8.49
|
14.43 percentage of saturation
Standard Deviation 9.62
|
POST_HOC outcome
Timeframe: Baseline to day 35Safety Incidence of s-phosphate level ≤1.0 mg/dL at any time from baseline to day 35.
Outcome measures
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=61 Participants
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=56 Participants
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Incidence of S-phosphate Level ≤1.0 mg/dL at Any Time From Baseline to Day 35
|
0 Participants
|
6 Participants
|
Adverse Events
Iron Isomaltoside/Ferric Derisomaltose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Ferric Carboxymaltose
Serious events: 1 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 participants at risk
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/62 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
1.8%
1/57 • Number of events 1 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
Other adverse events
| Measure |
Iron Isomaltoside/Ferric Derisomaltose
n=62 participants at risk
Iron isomaltoside/ferric derisomaltose, administered IV
|
Ferric Carboxymaltose
n=57 participants at risk
Ferric carboxymaltose, administered IV
|
|---|---|---|
|
Investigations
Blood parathyroid hormone increased
|
6.5%
4/62 • Number of events 4 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
8.8%
5/57 • Number of events 5 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/62 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
14.0%
8/57 • Number of events 9 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/62 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
5.3%
3/57 • Number of events 3 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Gastrointestinal disorders
Nausea
|
4.8%
3/62 • Number of events 4 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
10.5%
6/57 • Number of events 6 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/62 • Number of events 1 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
5.3%
3/57 • Number of events 3 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
3.2%
2/62 • Number of events 2 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
24.6%
14/57 • Number of events 14 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.5%
4/62 • Number of events 4 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
1.8%
1/57 • Number of events 1 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
|
Nervous system disorders
Headache
|
4.8%
3/62 • Number of events 4 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
7.0%
4/57 • Number of events 9 • From the time subjects signed the informed consent form (CRF) and until they completed the study, all adverse events (AEs) or serious adverse events (SAEs) were reported in the CRF. The actual study duration was 35 days (or shorted if the study was discontinued). Overall, eligible subjects participated in the trial for approximately 9 weeks (including a 28 day screening period).
AE description: the event was described in precise, standard medical terminology (i.e. not necessarily the exact words used by the subject). If known, a specific diagnosis was stated. The Investigator described an AE regarding seriousness, severity, relatedness, and outcome. 1 subject received iron isomaltoside/ferric derisomaltose in error, thus the iron isomaltoside/ferric derisomaltose group included 62 subjects instead of 61 subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Before 1 year after completion of the Study report the Investigator must not publish details regarding the Protocol and the conduct or results of the Trial. However, if a joint publication is submitted for publication the individual Investigator has no right to publish results from his/her centre until such the joint publication is actually issued.
- Publication restrictions are in place
Restriction type: OTHER