Table 2.
Treatment-Related Adverse Events
| Adverse Event | Gefitinib Arm (n = 124) |
Placebo Arm (n = 129) |
||||
|---|---|---|---|---|---|---|
| Grade 3 (%) | Grade 4 (%) | Grade 5 (%) | Grade 3 (%) | Grade 4 (%) | Grade 5 (%) | |
| Allergic reaction | 1 | 2 | ||||
| Hemoglobin | 4 | |||||
| Leukopenia | 3 | 2 | 2 | 2 | ||
| Lymphopenia | 2 | 1 | 5 | 2 | ||
| Neutropenia | 2 | 1 | 1 | 2 | ||
| Thrombocytopenia | 1 | |||||
| Atrial fibrillation | 1 | 1 | ||||
| Ventricular flutter | 1 | |||||
| Hypotension | 2 | 1 | 2 | 1 | ||
| Left ventricular diastolic dysfunction | 1 | |||||
| Fatigue | 11 | 13 | 3 | |||
| Insomnia | 1 | |||||
| Weight loss | 1 | 2 | ||||
| International normalized ratio | 1 | |||||
| Partial thromboplastin time | 1 | |||||
| Nail changes | 1 | 1 | ||||
| Pruritus/itching | 1 | |||||
| Rash/desquamation | 2 | |||||
| Hand-foot reaction | 1 | |||||
| Death/sudden death | 2 | |||||
| Anorexia | 5 | 2 | ||||
| Dehydration | 6 | 1 | 5 | |||
| Diarrhea without prior colostomy | 11 | 2 | 2 | |||
| Dysphagia | 2 | 1 | ||||
| Fistula, colon/cecum/appendix | 1 | |||||
| Oral mucositis by examination | 2 | |||||
| Oral mucositis by symptoms | 2 | 2 | ||||
| Nausea | 6 | 3 | 1 | |||
| Perforation, duodenum | 1 | |||||
| Vomiting | 2 | 1 | 3 | |||
| Abdomen, hemorrhage NOS | 1 | |||||
| Esophagus, hemorrhage | 1 | |||||
| Oral cavity, hemorrhage | 1 | |||||
| Bronchus, hemorrhage | 1 | |||||
| Colitis, infectious | 1 | |||||
| Febrile neutropenia | 1 | |||||
| Infection with neutropenia | ||||||
| Grade 3-4 | ||||||
| Abdomen NOS | 1 | |||||
| Bladder | 1 | |||||
| Lung | 1 | |||||
| Blood | 1 | |||||
| Grade 0-2 | ||||||
| Abdomen | 1 | |||||
| Catheter | 2 | |||||
| Colon | 1 | |||||
| Lung | 3 | 1 | 5 | 1 | 1 | |
| Neck | 1 | 1 | ||||
| Skin | 1 | 3 | ||||
| Urinary tract | 1 | |||||
| Wound | 1 | |||||
| Blood | 2 | 1 | ||||
| Infection with unknown neutrophils, lung | 1 | |||||
| Infection with unknown neutrophils, skin | 1 | 1 | ||||
| Opportunistic infection with lymphopenia | 1 | |||||
| Infection, other | 1 | |||||
| Edema | ||||||
| Head and neck | 2 | 1 | ||||
| Limb | 1 | |||||
| Hypoalbuminemia | 1 | |||||
| Alkaline phosphatase | 1 | |||||
| ALT | 1 | |||||
| Creatinine | 1 | |||||
| Hyperglycemia | 2 | 1 | ||||
| Hypophosphatemia | 1 | |||||
| Hypokalemia | 1 | |||||
| Hyponatremia | 1 | 2 | 1 | |||
| Non-neuropathic lower extremity muscle weakness | 1 | 1 | ||||
| Non-neuropathic generalized weakness | 1 | 5 | ||||
| Trismus | 1 | |||||
| Neuropathy, motor | 1 | |||||
| Neuropathy, sensory | 3 | |||||
| Syncope | 2 | |||||
| Abdomen, pain | 1 | |||||
| Chest pain NOS | 1 | |||||
| Head/headache | 1 | |||||
| Adult respiratory distress syndrome | 1 | 1 | ||||
| Bronchospasm, wheezing | 1 | |||||
| Cough | 1 | |||||
| Dyspnea | 3 | 1 | 4 | 1 | ||
| Hypoxia | 1 | 1 | 1 | |||
| Pleural effusion, nonmalignant | 2 | 1 | ||||
| Pneumonitis/pulmonary infiltrates | 1 | 1 | 2 | |||
| Renal failure | 1 | |||||
| Thrombosis/embolism | 1 | |||||
| Vessel injury, carotid | 1 | |||||
| Worst degree | 37 | 6 | 5 | 36 | 12 | 2 |
NOTE. Grade 3, severe; grade 4, life threatening; grade 5, lethal.
Abbreviation: NOS, not otherwise specified.