Table 6

Clinical symptoms and laboratory abnormalities in each treatment strategy

Strategy I Strategy II Strategy III
Gastrointestinal (subjective)
 Nausea, vomiting, dyspepsia, epigastric pain, indigestion352139
 Diarrhoea1775
 Dysgeusia41
Gastrointestinal (objective)
 Gastric ulcer111
 Gastritis2
 Gastrointestinal bleeding1
 Colitis11
 Colorectal surgery1
Mucocutaneous
 Rash174710
 Stomatitis, mouth ulcers2124
 Alopecia137
 Photosensitivity1
Central nervous system
 Headache, dizziness, tinnitus, mood alterations979
 Concentration disturbances51
Renal
 Proteinuria (>0.1 g/l in 24 h)2112
 Raised serum creatinine (>120 μmol/l)789
 Oedema (pretibial)233
 Haematuria (macroscopic observation)12
 Foul odour urine11
Hepatotoxicity
 Raised transaminases or γGT6-150 (ALAT6-150>90 U/l, γGT>100 U/l)7923
Haematological
 Anaemia (Hb <6.5 mmol/l)21129
 Leucopenia (<3.5 × 109/l)93
 Thrombocytopenia (<150 × 109/l)3106
 Eosinophilia (>0.5 × 109/l)2
 Pancytopenia1
 Leucopenia and thrombocytopenia2
Respiratory system
 Persistent cough133
 Dyspnoea121
 Pneumonitis11
 Pulmonary disorder (other than pneumonitis)211
Disorders of eye or ear
 Disturbed vision (unspecified)425
 Cataract13
 Blepharitis21
 Conjunctivitis1
 Scleritis1
 Toxic keratitis1
 Ocular sarcoidosis1
 Glaucoma1
 Dry eyes/dry mouth1
 Impaired hearing1
Other
 Fever, infections121218
 Rheumatoid nodulosis432
 Weight loss43
 Fatigue32
 Neuropathy121
 Vertebral fracture, osteoporosis112
 Malignancy22
 Heart failure2
 Sexual impotence1
 Restless legs1
Total170212181
  • 6-150 γGT = γ-glutamyl transferase; ALAT = alanine aminotransferase.