Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Time frame · Change from Baseline to Week 12

A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline. A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation. An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate

Time frame · Change from Baseline to Week 12

The number of CSBMs per week.

12-Week Spontaneous Bowel Movement (SBM) Frequency Rate

Time frame · Change from Baseline to Week 12

A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.

12-Week Stool Consistency

Time frame · Change from Baseline to Week 12

The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: 1. = separate hard lumps like nuts \[difficult to pass\] 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges \[passed easily\] 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces \[entirely liquid\]

12-Week Severity of Straining

Time frame · Change from Baseline to Week 12

Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.

12-Week Abdominal Discomfort

Time frame · Change from Baseline to Week 12

Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."

12-Week Bloating

Time frame · Change from Baseline to Week 12

Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".

12-Week Constipation Severity

Time frame · Change from Baseline to Week 12

Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".