.0
22.2
General Disorders and General Administration Site Conditions
Asthenia
Fatigue
Mucosal inflammation
3.4
21.9
2.5
3.7
21.5
3.5
Isolated cases of serious adverse experiences, regardless of causality, of dehydration, enterocolitis, febrile neutropenia, hypertension, hypoesthesia, neutropenic sepsis, pneumonia, and sinus tachycardia were reported in the moderately emetogenic CINV clinical study.
Highly and Moderately Emetogenic Chemotherapy
The following additional clinical adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen:
Infections and infestations: candidiasis, herpes simplex, lower respiratory infection, pharyngitis, septic shock, upper respiratory infection, urinary tract infection.
Neoplasms benign, malignant and unspecified (including cysts and polyps): malignant neoplasm, non-small cell lung carcinoma.
Blood and lymphatic system disorders: anemia, febrile neutropenia, thrombocytopenia.
Metabolism and nutrition disorders: appetite decreased, diabetes mellitus, hypokalemia.
Psychiatric disorders: anxiety disorder, confusion, depression.
Nervous system: peripheral neuropathy, sensory neuropathy, taste disturbance, tremor.
Eye disorders: conjunctivitis.
Cardiac disorders: myocardial infarction, palpitations, tachycardia.
Vascular disorders: deep venous thrombosis, flushing, hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders: cough, dyspnea, nasal secretion, pneumonitis, pulmonary embolism, respiratory insufficiency, vocal disturbance.
Gastrointestinal disorders: acid reflux, deglutition disorder, dry mouth, dysgeusia, dysphagia, eructation, flatulence, obstipation, salivation increased.
Skin and subcutaneous tissue disorders: acne, diaphoresis, rash.
Musculoskeletal and connective tissue disorders: arthralgia, back pain, muscular weakness, musculoskeletal pain, myalgia.
Renal and urinary disorders: dysuria, renal insufficiency.
Reproductive system and breast disorders: pelvic pain.
Genral disorders and administrative site conditions: edema, malaise, rigors.
Investigations: weight loss.
Laboratory Adverse Experiences
Table 6 shows the percent of patients with laboratory adverse experiences reported at an incidence ≥3% in patients receiving highly emetogenic chemotherapy.
Table 6: Percent of Patients Receiving Highly Emetogenic Chemotherapy With Laboratory Adverse Experiences (Incidence ≥3%) — Cycle 1 Aprepitant Regimen
(N=544) Standard Therapy
(N=550)
ALT Increased
AST Increased
Blood Urea Nitrogen Increased
Serum Creatinine Increased
Proteinuria
6.0
3.0
4.7
3.7
6.8
4.3
1.3
3.5
4.3
5.3
The following additional laboratory adverse experiences (incidence >0.5% and greater than standard therapy), regardless of causality, were reported in patients treated with aprepitant regimen: alkaline phosphatase increased, hyperglycemia, hyponatremia, leukocytes increased, erythrocyturia, leukocyturia.
The adverse experiences of increased AST and ALT were generally mild and transient.
The following laboratory adverse experiences were repor |
