Table 2

Extent of exposure to TrasGEX, number of infusions administered in 3-weekly cycles and number (%) of patients with infusion related reactions (IRR)

Dose (mg)1260120240480720*Total
No. of patients333332237
Extent of exposure in days, median (range)†1 (1–170)86 (20–150)42 (1–150)71 (43–148)66 (43–561)44.5 (20–234)45 (1–561)
Number of infusions administered, median (range)†1 (1–9)5 (2–8)3 (1–3)4 (3–8)4 (3–27)3 (2–12)3 (1–27)
IRR at first infusion, no. patients (%)द
 Grade I1 (33)2 (67)0005 (23)8 (22)
 Grade II2 (67)1 (33)1 (33)1 (33)1 (33)3 (14)9 (24)
 Grade III001 (33)0001 (3)
 Total3 (100)3 (100)2 (67)1 (33)1 (33)8 (37)18 (49)
  • *Includes six patients in the 720 mg cohort and 16 patients in the 720 mg expansion cohort.

  • †Calculated until study closure (November 2013). Two patients continued treatment under named patient: one received two additional infusions before progressing; the other is in CR and received the drug until February 2017.

  • ‡Percentage is calculated using the number of patients in the column heading as denominator.

  • §Most frequent symptoms of IRR included fever (10 patients, 56%), chills (9 patients, 50%), feeling cold (3 patients, 17%), nausea (4 patients, 22%), vomiting (3 patients, 17%) and hypertension (2 patients, 11%). The same patient may have contributed to two or more symptoms.

  • ¶Only 13 IRRs in seven patients (five of them in one patient) were observed in the subsequent infusions: three in grade I, nine in grade II and one in grade III (the drug was withdrawn).