Table 2.

Most common adverse events (those occurring in at least 10% of patients in either treatment group; evaluable-for-safety population)

n (%)Gefitinib (n = 81)Docetaxel (n = 76)
All CTC gradesCTC grade 3/4All CTC gradesCTC grade 3/4
Gastrointestinal disorders
    Diarrhea21 (25.9)1 (1.2)12 (15.8)0 (0.0)
    Nausea13 (16.0)0 (0.0)14 (18.4)0 (0.0)
    Constipation9 (11.1)0 (0.0)9 (11.8)0 (0.0)
    Vomiting4 (4.9)0 (0.0)8 (10.5)0 (0.0)
    Stomatitis*3 (3.7)0 (0.0)9 (11.8)1 (1.3)
    Dyspepsia10 (12.3)0 (0.0)5 (6.6)0 (0.0)
General disorders
    Asthenic conditions*20 (24.7)1 (1.2)28 (36.8)3 (3.9)
    Chest pain7 (8.6)0 (0.0)12 (15.8)0 (0.0)
    Pain8 (9.9)2 (2.5)5 (6.6)0 (0.0)
Metabolism and nutrition disorders
    Anorexia*29 (35.8)0 (0.0)36 (47.4)2 (2.6)
Musculoskeletal and connective tissue disorders
    Myalgia4 (4.9)0 (0.0)29 (38.2)0 (0.0)
    Arthralgia3 (3.7)0 (0.0)9 (11.8)0 (0.0)
Nervous system disorders
    Neurotoxicity*17 (21.0)0 (0.0)21 (27.6)0 (0.0)
    Dizziness9 (11.1)0 (0.0)7 (9.2)0 (0.0)
Psychiatric disorders
    Insomnia13 (16.0)0 (0.0)18 (23.7)0 (0.0)
Respiratory, thoracic, and mediastinal disorders
    Cough25 (30.9)0 (0.0)25 (32.9)0 (0.0)
    Dyspnea20 (24.7)3 (3.7)21 (27.6)3 (3.9)
    Productive cough21 (25.9)0 (0.0)18 (23.7)0 (0.0)
    Hemoptysis9 (11.1)0 (0.0)4 (5.3)0 (0.0)
Skin and s.c. disorders
    Rash acneiform*61 (75.3)3 (3.7)6 (7.9)0 (0.0)
    Pruritus*40 (49.4)2 (2.5)5 (6.6)1 (1.3)
    Alopecia4 (4.9)0 (0.0)33 (43.4)0 (0.0)
    Dry skin12 (14.8)0 (0.0)0 (0.0)0 (0.0)
    Nail and nail bed conditions*2 (2.5)0 (0.0)9 (11.8)(0.0)

Abbreviation: CTC, common toxicity criteria.

  • *Grouped term (sum of several preferred terms).