Most adverse events were mild or moderate (Grade 1 or 2) and manageable1
3 out of 10 patients experienced Grade 3+ anemia
MDS and AML have not been observed in the niraparib/abiraterone acetate arm of the MAGNITUDE trial to date*
Adverse reactions (>10%) in BRCA+ mCRPC patients receiving AKEEGA™
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| AKEEGA™ + P (n=113) | Placebo + AAP (n=112) | |||
|---|---|---|---|---|
| Adverse Reaction | All Grades % | Grade 3-4 % | All Grades % | Grade 3-4 % |
| Musculoskeletal paina | 44 | 4 | 42 | 5 |
| Fatiguea | 43 | 5 | 30 | 4 |
| Constipation | 34 | 1 | 20 | 0 |
| Hypertensiona | 33 | 14 | 27 | 17 |
| Nausea | 33 | 1 | 21 | 0 |
| Edemaa | 17 | 0 | 9 | 0 |
| Dyspneaa | 15 | 1 | 8 | 3 |
| Decreased appetite | 15 | 2 | 8 | 0 |
| Vomiting | 15 | 0 | 7 | 1 |
| Dizzinessa | 14 | 0 | 10 | 0 |
| COVID-19a | 13 | 7 | 9 | 4 |
| Abdominal paina | 12 | 2 | 12 | 1 |
| Hemorrhagea | 12 | 2 | 8 | 1 |
| Headache | 12 | 1 | 9 | 0 |
| Urinary tract infectiona | 12 | 3 | 9 | 1 |
| Cougha | 12 | 0 | 6 | 0 |
| Insomnia | 12 | 0 | 4 | 0 |
| Weight decreased | 10 | 1 | 4 | 1 |
| Arrhythmiaa | 10 | 2 | 4 | 1 |
| Fall | 10 | 1 | 13 | 4 |
| Pyrexiaa | 10 | 2 | 6 | 0 |
Select lab abnormalities (>10%) that worsened from baseline in BRCA+ mCRPC patients receiving AKEEGA™
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| AKEEGA™ + P (n=113)b | Placebo + AAP (n=112)b | |||
|---|---|---|---|---|
| Laboratory Abnormality | All Grades % | Grade 3-4 % | All Grades % | Grade 3-4 % |
| Hematology | ||||
| Hemoglobin decreased | 67 | 26 | 53 | 7 |
| Lymphocyte decreased | 55 | 22 | 32 | 13 |
| WBC decreased | 48 | 6 | 18 | 0.9 |
| Platelets decreased | 37 | 8 | 22 | 1.8 |
| Neutrophils decreased | 32 | 7 | 16 | 2.7 |
| Chemistry | ||||
| ALP increased | 34 | 1.8 | 29 | 1.8 |
| Creatinine increased | 30 | 0 | 13 | 1.8 |
| Potassium increased | 25 | 0.9 | 21 | 3.6 |
| Potassium decreased | 20 | 5 | 20 | 5 |
| AST increased | 20 | 1.8 | 25 | 2.7 |
| ALT increased | 18 | 0.9 | 17 | 4.5 |
| Bilirubin increased | 12 | 0 | 10 | 0.9 |
aIncludes multiple similar terms.
bThe denominator used to calculate the rate varied from 111 to 112 for placebo with abiraterone acetate and prednisone and 113 for AKEEGA™ with prednisone based on the number of patients with a baseline value and at least one post-treatment value.
85%
of BRCA+ mCRPC patients remained on AKEEGA™ without discontinuing due to TEAEs†
72%
of BRCA+ mCRPC patients did not need a dose reduction with AKEEGATM‡
50%
of BRCA+ mCRPC patients remained on AKEEGA™ without interruption due to TEAEs§
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