Trial Outcomes & Findings for IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose (NCT NCT02130063)
NCT ID: NCT02130063
Last Updated: 2018-09-27
Results Overview
The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder. Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
From baseline to week 5
Results posted on
2018-09-27
Participant Flow
Participant milestones
| Measure |
Iron Isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Overall Study
STARTED
|
342
|
169
|
|
Overall Study
COMPLETED
|
317
|
152
|
|
Overall Study
NOT COMPLETED
|
25
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
Baseline characteristics by cohort
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=342 Participants
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=169 Participants
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
Total
n=511 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.3 years
STANDARD_DEVIATION 15.8 • n=99 Participants
|
46.8 years
STANDARD_DEVIATION 14.9 • n=107 Participants
|
48.4 years
STANDARD_DEVIATION 15.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
309 Participants
n=99 Participants
|
154 Participants
n=107 Participants
|
463 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
342 participants
n=99 Participants
|
169 participants
n=107 Participants
|
511 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to week 5Population: Full analysis set (FAS) (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder. Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.
Outcome measures
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=330 Participants
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=161 Participants
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
|
226 participants
|
83 participants
|
SECONDARY outcome
Timeframe: From baseline to week 2, 4 and 5Population: FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Outcome measures
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=330 Participants
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=161 Participants
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Change in Hb Concentration
Week 2
|
1.56 g/dL
Standard Deviation 1.03
|
0.87 g/dL
Standard Deviation 0.90
|
|
Change in Hb Concentration
Week 4
|
2.35 g/dL
Standard Deviation 1.32
|
1.74 g/dL
Standard Deviation 1.17
|
|
Change in Hb Concentration
Week 5
|
2.52 g/dL
Standard Deviation 1.41
|
2.05 g/dL
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: From baseline to week 1, 2, 4, and 5Population: FAS (N = 491): The FAS consisted of all subjects who were randomised, received at least one dose of the trial drug, and had at least one post-baseline Hb assessment.
Outcome measures
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=330 Participants
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=161 Participants
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Change in Serum (s)-Ferritin Concentration
Week 5
|
241.2 ng/mL
Standard Deviation 209.3
|
185.7 ng/mL
Standard Deviation 166.8
|
|
Change in Serum (s)-Ferritin Concentration
Week 1
|
431.2 ng/mL
Standard Deviation 221.4
|
86.9 ng/mL
Standard Deviation 84.8
|
|
Change in Serum (s)-Ferritin Concentration
Week 2
|
516.6 ng/mL
Standard Deviation 268.1
|
126.2 ng/mL
Standard Deviation 87.2
|
|
Change in Serum (s)-Ferritin Concentration
Week 4
|
285.3 ng/mL
Standard Deviation 205.2
|
195.0 ng/mL
Standard Deviation 126.2
|
SECONDARY outcome
Timeframe: From baseline to week 1, 2, 4, and 5Outcome measures
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=330 Participants
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=161 Participants
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Change in Transferrin Saturation (TSAT)
Week 1
|
15.7 percent
Standard Deviation 9.6
|
3.3 percent
Standard Deviation 8.1
|
|
Change in Transferrin Saturation (TSAT)
Week 2
|
17.9 percent
Standard Deviation 9.8
|
5.7 percent
Standard Deviation 6.8
|
|
Change in Transferrin Saturation (TSAT)
Week 4
|
16.3 percent
Standard Deviation 9.0
|
11.5 percent
Standard Deviation 9.5
|
|
Change in Transferrin Saturation (TSAT)
Week 5
|
15.6 percent
Standard Deviation 8.6
|
11.8 percent
Standard Deviation 9.5
|
Adverse Events
Iron Isomaltoside 1000 (Monofer®)
Serious events: 11 serious events
Other events: 100 other events
Deaths: 1 deaths
Iron Sucrose (Venofer®)
Serious events: 6 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=333 participants at risk
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=168 participants at risk
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Enteritis
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
General disorders
Stent malfunction
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant mediastinal neoplasm
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Nervous system disorders
Syncope
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Nervous system disorders
Vith nerve paralysis
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum haemorrhage
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.30%
1/333 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.00%
0/168 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/333 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
Other adverse events
| Measure |
Iron Isomaltoside 1000 (Monofer®)
n=333 participants at risk
iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
|
Iron Sucrose (Venofer®)
n=168 participants at risk
iron sucrose (Venofer®)
iron sucrose (Venofer®)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
5.1%
17/333 • Number of events 19 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
4.2%
7/168 • Number of events 8 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
7/333 • Number of events 7 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
3.0%
5/168 • Number of events 6 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Infections and infestations
Urinary tract infection
|
2.1%
7/333 • Number of events 7 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
7/333 • Number of events 9 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
1.2%
2/168 • Number of events 2 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
8/333 • Number of events 8 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
1.2%
2/168 • Number of events 3 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Nervous system disorders
Dizziness
|
2.7%
9/333 • Number of events 10 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
2.4%
4/168 • Number of events 5 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Nervous system disorders
Headache
|
5.4%
18/333 • Number of events 21 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
6.5%
11/168 • Number of events 13 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.2%
14/333 • Number of events 18 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
0.60%
1/168 • Number of events 1 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
3/333 • Number of events 3 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
3.0%
5/168 • Number of events 7 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Nervous system disorders
Dysgeusia
|
0.60%
2/333 • Number of events 2 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
3.0%
5/168 • Number of events 10 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
General disorders
Fatique
|
1.2%
4/333 • Number of events 4 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
3.0%
5/168 • Number of events 8 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
4/333 • Number of events 4 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
3.6%
6/168 • Number of events 6 • From screening until week 5
The nature of the event will be described in precise, standard medical terminology. If known, a specific diagnosis was stated. Furthermore the Investigator described an AE regarding seriousness, severity, relatedness, and outcome. It is only the subjects that received treatment that is included in the safety analysis. Of the 342 enrolled subjects in the Monofer arm only 333 was treated. Of the 169 subjects enrolled in the Venofer arm 168 was treated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place