Table 1.

Screening criteria to identify potential cases of ischemic colitis and serious complications of constipation in patients receiving alosetron (identified from pooled clinical trial data). [Adapted with permission from Chang et al. 2006].

Probable ischemic colitis (IC)	Probable serious complications of constipation (CoC)
• Medical history consistent with IC (e.g. abdominal discomfort, hematochezia, diarrhea) and … • Supported by the results of colonoscopy or other imaging tests and /or histological evaluation of a relevant tissue biopsy and … • No evidence for any more likely diagnosis	• Medical history consistent with serious CoC (e.g. patient complained of constipation) and met regulatory definition of a serious adverse event* • Medical history is supported by hospital or medical records
	• Colonoscopy results (or other imaging test) do not identify a more likely diagnosis for the patient’s symptoms

^*Serious adverse event is defined as ‘death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect.’ Serious adverse events also include: ‘important medical events that may not result in death, be life-threatening, or require hospitalization … [but] based upon appropriate medical judgment, they may jeopardize the patients and may require medical or surgical intervention to prevent one of the outcomes listed in the definition.’