Table 3.
Number (%) of patients with adverse events, by body system and preferred term, by relation to study drug.
| Table 3.1. Number (%) of patients with adverse events, by body system and preferred term, by relation to study drug. | |||
|---|---|---|---|
| Imatinib mesylate | |||
| N = 95 | not related | related | total |
| Gastrointestinal disorders | 67(70.5) | ||
| Nausea | 9(9.5) | 27(28.4) | 36(37.9) |
| abdominal pain | 23(24.2) | 4 (4.2)27(28.4) | |
| Diarrhea | 6(6.3) | 20(21.1) | 26(27.4) |
| Vomiting | 8(8.4) | 9(9.5) | 17(17.9) |
| constipation | 10(10.5) | 4(4.2) | 14(14.7) |
| Flatulence | 5(5.3) | 6(6.3) | 11(11.6) |
| abdominal discomfort | 8(8.4) | 2(2.1) | 10(10.5) |
| Dyspepsia | 2(2.1) | 3(3.2) | 5(5.3) |
| abdominal pain | 2(2.1) | 2(2.1) | 4(4.2) |
| Subileus | 4(4.2) | -- | 4(4.2) |
| Melaena | 3(3.2) | -- | 3(3.2) |
| Stomatitis | 3(3.2) | -- | 3(3.2) |
| General disorders | 54(56.8) | ||
| oedema peripheral | 6(6.3) | 23(24.2) | 29(30.5) |
| fatigue | 9(9.5) | 13(13.7) | 22(23.2) |
| oedema | 1(1.1) | 9(9.5) | 10(10.5) |
| pain | 7(7.4) | 2(2.1) | 9(9.5) |
| asthenia | 3(3.2) | 6(6.3) | 9(9.5) |
| fever | 6(6.3) | 1(1.1) | 7(7.4) |
| chest pain | 33.2) | -- | 3(3.2) |
| Musculoskeletal and connective tissue disorders | 35(36.8) | ||
| muscle cramp | 2(2.1) | 15(15.8) | 17(17.9) |
| arthralgia | 8(8.4) | 2(2.1) | 10(10.5) |
| pain (extremities) | 6(6.3) | -- | 6(6.2) |
| back pain | 4(4.2) | 1(1.1) | 5(5.3) |
| myalgia | 1(1.1) | 3(3.2) | 4(4.2) |
| Skin and subcutaneous tissue disorders | 34(35.8) | ||
| periorbital oedema | -- | 8(8.4) | 8(8.4) |
| exanthema | 1(1.1) | 6(6.3) | 7(7.4) |
| face oedema | -- | 6(6.3) | 6(6.3) |
| hyperhidrosis | 3(3.2) | 2(2.1) | 5(5.3) |
| alopecia | 1(1.1) | 2(2.1) | 3(3.2) |
| dry skin | -- | 3(3.2) | 3(3.2) |
| erythema | -- | 3(3.2) | 3(3.2) |
| night sweats | 2(2.2) | 1(1.1) | 3(3.2) |
| pruritus | -- | 3(3.2) | 3(3.2) |
| scar pain | 3(3.2) | -- | 3(3.2) |
| Table 3.2. Number (%) of patients with adverse events, by body system and preferred term, by relation to study drug. | |||
| N = 95 | Imatinib mesylate | ||
| not related | related | total | |
| Eye disorders | 27(28.4) | ||
| eyelid oedema | -- | 23(24.2) | 23(24.2) |
| conjunctivitis | -- | 6(6.3) | 6(6.3) |
| lacrimation increased | -- | 3(3.2) | 3(3.2) |
| Nervous system disorders | 23(24.1) | ||
| dizziness | 3(3.2) | 8(8.4) | 11(11.6) |
| headache | 6(6.3) | 3(3.2) | 9(9.5) |
| paraesthesia | -- | 3(3.2) | 3(3.2) |
| Blood and lymphatic system disorders | 21(22.1) | ||
| anaemia | 7(7.4) | 9(9.5) | 16(16.8) |
| leukopenia | -- | 4(4.2) | 4(4.2) |
| Psychiatric disorders | 19(20.0) | ||
| insomnia | 8(8.4) | 1(1.1) | 9(9.5) |
| anxiety | 5(5.3) | -- | 5(5.3) |
| depression | 3(3.2) | 2(2.1) | 5(5.3) |
| sleep disorder | 2(2.1) | 2(2.1) | 4(4.2) |
| Metabolism and nutrition disorders | 18(19.0) | ||
| anorexia | 7(7.4) | 4(4.2) | 11(11.6) |
| hypokalaemia | 6(6.3) | 1(1.1) | 7(7.4) |
| hyperuricaemia | 3(3.2) | -- | 3(3.2) |
| Infections | 18(19.0) | ||
| nasopharyngitis | 6(6.3) | -- | 6(6.3) |
| urinary tract infection | 3(3.2) | -- | 3(3.2) |
| Respiratory, thoracic and mediastinal disorders | 12(12.6) | ||
| cough | 4(4.2) | -- | 4(4.2) |
| pleural effusion | 3(3.2) | -- | 3(3.2) |
| Vascular disorders | 9(9.5) | ||
| hypertension | 4(4.2) | -- | 4(4.2) |
| Laboratory findings | 37(39.0) | ||
| blood lactate dehydrogenase increased | 6(6.3) | 6(6.3) | 12(12.6) |
| blood bililrubin increased | 2(2.1) | 8(8.4) | 10(10.5) |
| blood alkaline phosphatase increased | 5(5.3) | 4(4.2) | 9(9.5) |
| blood creatinine increased | 2(2.1) | 6(6.3) | 8(8.4) |
| blood urea increased | 3(3.2) | 4(4.2) | 7(7.4) |
| alanine aminotransferase (ALT) increased | 2(2.1) | 4(4.2) | 6(6.3) |
| aspartate aminotransferase (AST) increased | 2(2.1) | 4(4.2) | 6(6.3) |
| blood uric acid increased | 6(6.3) | -- | 66.3) |
| haemoglobin decreased | 1(1.1) | 4(4.2) | 5(5.3) |
| hepatic enzyme increased | 1(1.1) | 3(3.2) | 4(4.2) |