t of normal (ULN) (≤5times ULN if lymphomatous liver infiltration). Patients with active autoimmune disease, active
infection, autologous HSCT within 90 days, or prior allogeneic HSCT were excluded.
During randomized treatment, the median duration of exposure to POTELIGEO was 5.6 months,with 48% (89/184) of patients with at least 6 months of exposure and 23% (43/184) with at least12 months of exposure. The median duration of exposure to vorinostat was 2.8 months, with22% (41/186) of patients with at least 6 months of exposure.
Fatal adverse reactions within 90 days of the last dose occurred in 2.2% (7/319) of patients whoreceived POTELIGEO as randomized or crossover treatment.
Serious adverse reactions were reported in 36% (66/184) of patients randomized to POTELIGEOand most often involved infection (16% of patients; 30/184). Serious adverse reactions reportedin >2% of patients randomized to POTELIGEO were pneumonia (5%), sepsis (4%), pyrexia(4%), and skin infection (3%); other serious adverse reactions, each reported in 2% of patients,included hepatitis, pneumonitis, rash, infusion related reaction, lower respiratory tract infection,and renal insufficiency. POTELIGEO was discontinued for adverse reactions in 18% ofrandomized patients, most often due to rash or drug eruption (7.1%).
Common Adverse Reactions
The most common adverse reactions (reported in ≥20% of patients randomized to POTELIGEO)were rash (including drug eruption), infusion related reactions, fatigue, diarrhea, upperrespiratory tract infection and musculoskeletal pain. Other common adverse reactions (reportedin ≥10% of patients randomized to POTELIGEO) included skin infection, pyrexia, nausea,edema, thrombocytopenia, headache, constipation, mucositis, anemia, cough and hypertension.
Table 1 summarizes common adverse reactions having a ≥2% higher incidence with
POTELIGEO than with vorinostat in Trial 1.
Table 1: Common Adverse Reactions (≥10%) with ≥2% Higher Incidence in the POTELIGEO
Arm
Adverse Reactions
by Body System a, b
POTELIGEO
(N=184)
Vorinostat
(N=186)
All Grades
(%)
≥Grade 3
(%)
All Grades
(%)
≥Grade 3
(%)
Skin and Subcutaneous Tissue Disorders
Rash, Including Drug Eruption 35 5 11 2
Drug Eruption 24 5 <1 0
Procedural Complications
Infusion Related Reaction 33 2 0 0
Infections
Upper Respiratory Tract Infection 22 0 16 1
Skin Infection 19 3 13 4
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal Pain 22 <1 17 3
General Disorders
Pyrexia 17 <1 7 0
Gastrointestinal
Mucositis 12 1 6 0
a Adverse reactions include groupings of individual preferred terms.
b Includes adverse reactions reported up to 90 days after randomized treatment.
Rash/Drug Eruption includes: dermatitis (allergic, atopic, bullous, contact, exfoliative, infected), drug eruption,palmoplantar keratoderma, rash (generalized, macular, maculopapular, papular, pruritic, pustular), skin reaction,toxic skin eruption Upper Respiratory Tract Infection includes: laryngitis viral, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upperrespiratory tract infection, viral upper respiratory tract infectionSkin Infection includes: cellulitis, dermatitis infected, erysipelas, impetigo, infected skin ulcer, periorbital cellulitis,skin bacterial infection, skin infection, staphylococcal skin infectionMusculoskeletal Pain includes: back pain, |
