Key baseline characteristics related to iron overload
| Criteria, n (%)∗ . | Mitapivat N = 78 . |
|---|---|
| Baseline ferritin of >1000 μg/L† | |
| Yes | 15 (19.2) |
| No | 61 (78.2) |
| Missing | 2 (2.6) |
| Baseline average LIC by MRI of >3 mg Fe/g dw‡ | |
| Yes | 39 (50.0) |
| No | 37 (47.4) |
| Missing | 2 (2.6) |
| Prior chelation status§ | |
| Yes | 16 (20.5) |
| No | 62 (79.5) |
| Iron overload at baseline|| | |
| Yes | 43 (55.1) |
| No | 35 (44.9) |
| Criteria, n (%)∗ . | Mitapivat N = 78 . |
|---|---|
| Baseline ferritin of >1000 μg/L† | |
| Yes | 15 (19.2) |
| No | 61 (78.2) |
| Missing | 2 (2.6) |
| Baseline average LIC by MRI of >3 mg Fe/g dw‡ | |
| Yes | 39 (50.0) |
| No | 37 (47.4) |
| Missing | 2 (2.6) |
| Prior chelation status§ | |
| Yes | 16 (20.5) |
| No | 62 (79.5) |
| Iron overload at baseline|| | |
| Yes | 43 (55.1) |
| No | 35 (44.9) |
The denominator used to calculate percentages is N, the number of subjects in the full analysis set.
Ferritin values reported as >1500 μg/L because of a laboratory dilution error were excluded; the baseline for ferritin is the average of all assessments within 45 (42 + 3) days before the start of treatment with mitapivat; assessments collected within 61 days after a transfusion were excluded from the baseline derivation.
The baseline for average LIC by MRI is defined as the last assessment before the start of treatment with mitapivat.
Prior chelation status was established as part of medical history to distinguish from assessment of chelation on treatment; “Yes” if a subject had received chelation therapy within 52 weeks (364 days) before the start of treatment with mitapivat.
“Yes” if subject met at least 1 of 3 criteria: baseline ferritin of >1000 μg/L, baseline average LIC of >3 mg Fe/g dw, and/or prior chelation status = Yes.