able lists the different types of infections that were reported as adverse events during the initial phase of the SWOG study. There were no apparent differences in the types of infection between the 2 treatment groups, with the possible exception of herpes zoster which was reported more frequently for NIPENT (8%) than for IFN (1%).
The drug relatedness of the adverse events listed below cannot be excluded. The following adverse events occurred in 3% to 10% of NIPENT-treated patients in the initial phase of the SWOG study:
Body as a Whole —Chest Pain, Death, Face Edema, Peripheral Edema
Cardiovascular System —Hemorrhage, Hypotension
Digestive System —Dental Abnormalities, Dyspepsia, Flatulence, Gingivitis
Hemic and Lymphatic System —Agranulocytosis
Laboratory Deviations —Elevated Creatinine
Musculoskeletal System —Arthralgia
Nervous System —Confusion, Dizziness, Insomnia, Paresthesia, Somnolence
Psychobiologic Function —Anxiety, Depression, Nervousness
Respiratory System —Asthma
Skin & Appendages —Skin Dry, Urticaria
The remaining adverse events which occurred in less than 3% of NIPENT-treated patients during the initial phase of the SWOG study:
Body as a Whole —Flu-like Symptoms, Hangover Effect, Neoplasm
Cardiovascular System —Angina Pectoris, Arrhythmia, A-V Block, Bradycardia, Extrasystoles Ventricular, Heart Arrest, Heart Failure, Hypertension, Pericardial Effusion, Phlebitis, Pulmonary Embolus, Sinus Arrest, Tachycardia, Thrombophlebitis Deep, Vasculitis
Digestive System —Constipation, Dysphagia, Glossitis, Ileus
Hemic and Lymphatic System —Acute Leukemia, Anemia-Hemolytic, Aplastic Anemia
Laboratory Deviations —Hypercalcemia, Hyponatremia
Musculoskeletal System —Arthritis, Gout
Nervous System —Amnesia, Ataxia, Convulsions, Dreaming Abnormal, Dysarthria, Encephalitis, Hyperkinesia, Meningism, Neuralgia, Neuritis, Neuropathy, Paralysis, Syncope, Twitching, Vertigo
Psychobiologic Function —Decrease/Loss Libido, Emotional Lability, Hallucination, Hostility, Neurosis, Thinking Abnormal
Respiratory System —Bronchospasm, Larynx Edema
Skin and Appendages —Acne, Alopecia, Eczema, Petechial Rash, Photosensitivity Reaction
Special Senses —Amblyopia, Deafness, Earache, Eyes Dry, Labyrinthitis, Lacrimation Disorder, Nonreactive Eye, Photophobia, Retinopathy, Tinnitus, Unusual Taste, Vision Abnormal, Watery Eyes
Urogenital System —Amenorrhea, Breast Lump, Impotence, Kidney Function Abnormal, Nephropathy, Renal Failure, Renal Insufficiency, Renal Stone
One patient with hairy cell leukemia treated with NIPENT during another clinical study developed unilateral uveitis with vision loss.
Nineteen (5%) patients withdrew from the Phase 3 SWOG 8691 study because of adverse events; 9 during initial NIPENT treatment, 4 during NIPENT crossover, 5 during initial IFN treatment, and 1 during both initial IFN treatment and NIPENT crossover. In the Phase 2 studies in IFN-refractory hairy cell leukemia, 11% of patients withdrew from treatment with NIPENT due to an adverse event.
Percent of Patients
All Adverse Eventsa Frontline, Frontline, IFN-Refractor
