Table 3. Adverse events of special interest to chemotherapy and key events pooled by body system (treatment-related and unrelated).
FOLFOX4/FOLFOX4-placebo (n=648)
|
XELOX/ XELOX-placebo (n=655)
|
|||||||
---|---|---|---|---|---|---|---|---|
All-grade | Grade 3/4 | All-grade | Grade 3/4 | |||||
No. | % | No. | % | No. | % | No. | % | |
All events | 644 | 99 | 506 | 78 | 649 | 99 | 468 | 72 |
Body system | ||||||||
Gastrointestinal disorders | 603 | 93 | 167 | 26 | 606 | 93 | 216 | 33 |
Blood/lymphatic disorders | 448 | 69 | 318 | 49 | 312 | 48 | 104 | 16 |
Infections/infestations | 292 | 45 | 66 | 10 | 210 | 32 | 45 | 7 |
Events of special interest | ||||||||
Neurosensory toxicitya | 515 | 80 | 107 | 17 | 534 | 82 | 114 | 17 |
Diarrhoea | 394 | 61 | 74 | 11 | 429 | 66 | 133 | 20 |
Nausea/vomiting | 452 | 70 | 47 | 7 | 464 | 71 | 52 | 8 |
Stomatitis | 242 | 37 | 13 | 2 | 140 | 21 | 8 | 1 |
Neutropenia/granulocytopenia | 379 | 59 | 282 | 44 | 180 | 28 | 46 | 7 |
Febrile neutropenia | — | — | 31 | 5 | — | — | 6 | <1 |
Hand-foot syndrome | 70 | 11 | 8b | 1b | 201 | 31 | 40b | 6b |
Abbreviations: FOLFOX4=infused 5-fluorouracil, folinic acid and oxaliplatin; XELOX=capecitabine and oxaliplatin.
Pooled term that includes burning sensation, dysaesthesia, hyper or hypoaesthesia, neuropathic pain, neuropathy, peripheral neuropathy, neurotoxicity, paraesthesia, peripheral (sensi)motor neuropathy, (chronic) polyneuropathy, sensory disturbance or loss, skin burning sensation, temperature intolerance, neuralgia, peroneal nerve palsy, autonomic neuropathy.
Grade 3 events only.