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) |