Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
iron isomaltoside 1000 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| iron isomaltoside 1000 (Monofer®) | EXPERIMENTAL | iron isomaltoside 1000 (Monofer®) |
| iron sucrose (Venofer®) | ACTIVE_COMPARATOR | iron sucrose (Venofer®) |
| Name | Type | Description |
|---|---|---|
| iron isomaltoside 1000 (Monofer®) | DRUG | - |
| iron sucrose (Venofer®) | DRUG | - |
Inclusion Criteria: 1. Men or women \> 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of ...