Table 4.
| Table 4a. Acute Adverse Events Among Treated Patients | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CD Grade Frequency (N = 261) | CDP Grade Frequency (N = 278) | |||||||||
| Adverse Event term or category | 0 | 1 | 2 | 3 | 4 | 0 | 1 | 2 | 3 | 4 |
| Leukopenia* | 28 | 43 | 58 | 100 | 32 | 7 | 21 | 37 | 95 | 118 |
| Neutropenia* | 71 | 32 | 36 | 63 | 59 | 21 | 21 | 46 | 58 | 132 |
| Thrombocytopenia* | 114 | 92 | 28 | 26 | 1 | 35 | 127 | 49 | 62 | 5 |
| Anemia* | 36 | 88 | 106 | 30 | 1 | 15 | 58 | 162 | 43 | 0 |
| Gastrointestinal | 109 | 79 | 57 | 13 | 3 | 108 | 82 | 67 | 18 | 3 |
| Nausea | 67 | 105 | 65 | 24 | 0 | 81 | 102 | 66 | 29 | 0 |
| Vomiting | 132 | 54 | 52 | 21 | 2 | 141 | 58 | 55 | 23 | 1 |
| Stomatitis | 228 | 22 | 10 | 0 | 1 | 237 | 26 | 13 | 2 | 0 |
| Genitourinary/Renal | 195 | 48 | 14 | 4 | 0 | 214 | 37 | 23 | 3 | 1 |
| Infection/Fever* | 247 | 3 | 7 | 3 | 1 | 239 | 4 | 13 | 19 | 3 |
| Febrile Neutropenia* | 259 | 1 | 1 | 0 | 0 | 261 | 0 | 3 | 13 | 1 |
| Sensory neuropathy* | 183 | 65 | 8 | 5 | 0 | 94 | 108 | 52 | 23 | 1 |
| Pain* | 126 | 72 | 46 | 16 | 1 | 108 | 69 | 74 | 27 | 0 |
| Myalgia* | 243 | 11 | 7 | 0 | 0 | 198 | 28 | 45 | 7 | 0 |
| Table 4b. Late Adverse Events Among Treated Patients | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CD Grade Frequency (N = 261) | CDP Grade Frequency (N = 278) | |||||||||||
| Organ System | 0 | 1 | 2 | 3 | 4 | 5 | 0 | 1 | 2 | 3 | 4 | 5 |
| Bladder | 237 | 13 | 11 | 2 | 1 | 0 | 246 | 12 | 16 | 3 | 1 | 0 |
| Bone | 250 | 3 | 3 | 3 | 2 | 0 | 261 | 5 | 8 | 3 | 2 | 0 |
| Skin | 249 | 6 | 5 | 0 | 1 | 0 | 260 | 9 | 5 | 3 | 1 | 0 |
| Sm or Lg Intestine | 184 | 42 | 14 | 13 | 8 | 0 | 185 | 46 | 23 | 19 | 6 | 1 |
|
| ||||||||||||
| Grade 3–5 Sm or Lg Intestine AE re-review* | 5 | 13 | 3 | 0 | 16 | 7 | 2 | 1 | ||||
CD = cisplatin and doxorubicin
CDP = cisplatin, doxorubicin and paclitaxel
*
p<0.01
*
All patients were not at risk for the entire follow-up period due to competing risks. All grade 3–5 small or large intestine adverse effects reported were re-reviewed and graded for attribution to study treatment and not disease. Those adverse events thought to be related to study treatment during follow-up with obstruction or bleeding requiring surgery were classified as grade 3, with necrosis, perforation or fistula were classified as grade 4, or that resulted in death were classified as grade 5.
CD = cisplatin and doxorubicin
CDP = cisplatin, doxorubicin and paclitaxel
Sm = Small, Lg = Large
AE = Adverse Event