Table 11

Primary and secondary outcome variables in the valid for efficacy analysis

Outcome variablesTotal (n=251)Treatment groups
Placebo (n=90)O1
(n=78)
O2
(n=83)
Death27 (11%)13 (14%)7 (9%)7 (8%)
 Death ⩽14 days4121
 Death >14/⩽30 days8323
 Death >30 days15933
Patients with newly developed complications180 (73%)61 (68%)59 (76%)60 (72%)
Duration of pain (days)3-150 6 (0–209)6 (0–209)6 (0–105)7 (1–89)
Hospital stay (days)3-150 21 (5–210)22 (7–210)21 (5–105)20 (7–163)
  • 3-150 Median values (range).