Table 3.
Incidence of non-hematological toxicities grade 3 and 4 by randomization
| Treatment arm | All randomized and evaluable patients in the study | |||||
|---|---|---|---|---|---|---|
| Total patients | Standard | S-HAM | ||||
| n/N (%) | n/N (%) | n/N (%) | ||||
| Alopecia | 141/259 | (54.4) | 70/132 | (53.0) | 71/127 | (56.0) |
| Infection | 166/349 | (47.6) | 80/181 | (44.2) | 86/168 | (51.2) |
| Pulmonary toxicity | 66/352 | (18.8) | 28/181 | (15.5) | 38/171 | (22.2) |
| Prothrombin | 17/281 | (6.0) | 6/149 | (4.0) | 11/132 | (8.3) |
| Fever | 45/353 | (12.7) | 26/183 | (14.2) | 19/170 | (11.2) |
| Diarrhea | 39/352 | (11.1) | 17/181 | (9.4) | 22/171 | (12.9) |
| Pain | 55/351 | (15.7) | 22/180 | (12.2) | 33/171 | (19.3) |
| Nausea/vomiting | 31/351 | (8.8) | 16/180 | (8.9) | 15/171 | (8.8) |
| PCHE | 3/209 | (1.4) | 1/110 | (0.9) | 2/99 | (2.0) |
| Hypoproteinemia | 30/296 | (10.1) | 15/151 | (9.9) | 15/145 | (10.3) |
| Mucositis | 22/344 | (6.4) | 5/177 | (2.8) | 17/167 | (10.2) |
| Weight gain | 43/352 | (12.2) | 22/183 | (12.0) | 21/169 | (12.4) |
| Cardiac function | 12/346 | (3.5) | 8/179 | (4.5) | 4/167 | (2.4) |
| Bleeding | 25/350 | (7.1) | 8/183 | (4.4) | 17/167 | (10.2) |
| SGOT/SGPT | 37/351 | (10.5) | 18/180 | (10.0) | 19/171 | (11.1) |
| Central nervous system | 18/349 | (5.2) | 5/179 | (2.8) | 13/170 | (7.7) |
| Bilirubin | 16/352 | (4.5) | 6/181 | (3.3) | 10/171 | (5.9) |
| Effusion | 17/350 | (4.9) | 8/180 | (4.4) | 9/170 | (5.3) |
| Edema | 21/350 | (6.0) | 8/179 | (4.5) | 13/171 | (7.6) |
| Cutaneous toxicity | 8/348 | (2.3) | 2/181 | (1.1) | 6/167 | (3.6) |
| Alkaline phosphatase | 4/306 | (1.3) | 2/156 | (1.3) | 2/150 | (1.3) |
| Cardiac rhythm | 7/344 | (2.0) | 3/180 | (1.7) | 4/164 | (2.4) |
| Creatinine/renal toxicity | 3/352 | (0.9) | 3/181 | (1.7) | 0/171 | (0.0) |
| Obstipation | 5/351 | (1.4) | 2/181 | (1.1) | 3/170 | (1.8) |
| Hematuria | 1/347 | (0.3) | 1/179 | (0.6) | 0/168 | (0.0) |
| Extrapyramidal symptoms | 4/350 | (1.1) | 2/180 | (1.1) | 2/170 | (1.2) |
| Allergic reaction | 2/346 | (0.6) | 1/181 | (0.6) | 1/165 | (0.6) |
| Peripheral nervous system | 3/351 | (0.9) | 2/181 | (1.1) | 1/170 | (0.6) |
| Pericarditis | 0/346 | (0.0) | 0/178 | (0.0) | 0/168 | (0.0) |
PCHE pseudocholinesterase, SGOT/SGPT serum-glutamat-oxalacetat-transaminase/serum-glutamat-pyruvat-transferase