Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

Time frame · From first dose up to 72 weeks

All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

Time frame · From first dose up to 72 weeks

Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

Time frame · From first dose up to 72 weeks

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

Time frame · From first dose up to 72 weeks

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

Summary of Vital Signs at >Day 364 - Body Temperature (°C)

Time frame · From first dose up to 72 weeks

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

Time frame · From first dose up to 72 weeks

The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

Summary of ECG Results Shift From Baseline at > Day 364

Time frame · From first dose up to 72 weeks

Baseline was defined as the last non-missing value collected prior to first dose of study drug)

Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

Time frame · From first dose up to 72 weeks

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

Time frame · Form first dose up to 72 weeks

Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

Time frame · From first dose up to 72 weeks

Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

Time frame · From first dose up to 72 weeks

Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.

Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

Time frame · From first dose up to 72 weeks

Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely