Table 2.

Adverse events

All adverse eventsSerious adverse events (SAE)
Chemotherapy armCombination therapy armPaChemotherapy armCombination therapy armPa
Febrile neutropenia2553<0.0012553<0.001
Proteinuria3743NSb00NS
Hypertension1437<0.00100NS
Bleeding/hemorrhage1348<0.00112NS
Infection6160.0336150.055
Neutropenia35NS35NS
Fever23NS13NS
Stomatitis12NS12NS
Arrhythmia supraventricular12NS12NS
Hypersensitivity reaction20NS20NS
Syncope20NS20NS
Death01NS01NS
Otherc2118NS1012NS
  • aFisher's exact test.

  • bNS (not significant; P > 0.05).

  • cOther single SAE: In chemotherapy arm: Asthenia, chest pain, colitis, constipation, dehydration, injection site reaction, myalgia, nausea, periodontitis, superficial thrombophlebitis; in combination therapy arm: Decreased appetite, dizziness, extravasation, hypoesthesia, left ventricular dysfunction, nervous system disorder, noncardiac chest pain, esophageal candidiasis, pancreatitis, polyneuropathy, pulmonary embolism, and tubulointerstitial nephritis.