cL
cAlanine aminotransferase, aspartate aminotransferase, and transaminases increased
Any Adverse Event 111 100 48 43 34 31
Mucositisa 78 70 19 17 4 4
Thrombocytopeniab 45 41 15 14 21 19b
Nausea 44 40 4 4 0 0
Fatigue 40 36 5 5 2 2
Anemia 38 34 17 15 2 2
Constipation 37 33 0 0 0 0
Pyrexia 36 32 1 1 1 1
Edema 33 30 1 1 0 0
Cough 31 28 1 1 0 0
Epistaxis 29 26 0 0 0 0
Vomiting 28 25 2 2 0 0
Neutropenia 27 24 14 13 8 7
Diarrhea 23 21 2 2 0 0
Dyspnea 21 19 8 7 0 0
Anorexia 17 15 3 3 0 0
Hypokalemia 17 15 4 4 1 1
Rash 17 15 0 0 0 0
Pruritus 16 14 2 2 0 0
Pharyngolaryngeal pain 15 14 1 1 0 0
Liver function test abnormalc 14 13 6 5 0 0
Abdominal pain 13 12 4 4 0 0
Pain in extremity 13 12 0 0 0 0
Back pain 12 11 3 3 0 0
Leukopenia 12 11 3 3 4 4
Night sweats 12 11 0 0 0 0
Asthenia 11 10 1 1 0 0
Tachycardia 11 10 0 0 0 0
Upper respiratory tract infection 11 10 1 1 0 0
aStomatitis or mucosal inflammation of the gastrointestinal and genitourinary tracts.
bFive patients with platelets < 10,000/mcL
cAlanine aminotransferase, aspartate aminotransferase, and transaminases increased
Serious Adverse Events
Forty-four percent of patients (n = 49) experienced a serious adverse event while on study or within 30 days after their last dose of Folotyn. The most common serious adverse events (> 3%), regardless of causality, were pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia. One death from cardiopulmonary arrest in a patient with mucositis and febrile neutropenia was reported in this trial. Deaths from mucositis, febrile neutropenia, sepsis, and pancytopenia occurred in 1.2% of patients treated on all Folotyn trials at doses ranging from 30 to 325 mg/m2.
Discontinuations
Twenty-three percent of patients (n = 25) discontinued treatment with Folotyn due to adverse reactions. The adverse reactions reported most frequently as the reason for discontinuation of treatment were mucositis (6%, n = 7) and thrombocytopenia (5%, n = 5).
Dose Modifications
The target dose of Folotyn was 30 mg/m2 once weekly for 6 weeks in 7-week cycles. The majority of patients (69%, n = 77) remained at the target dose for the duration of treatment. Overall, 85% of scheduled doses were administered.
Post Marketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is |
