Trial Outcomes & Findings for A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide (NCT NCT05760313)
NCT ID: NCT05760313
Last Updated: 2026-01-06
Results Overview
An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Assess Adverse Events and Change in Disease Activity in Pediatric Participants (Age 6 Months to <2 Years) With Functional Constipation Who Are Treated With Linaclotide
Baseline characteristics by cohort
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
n=7 Participants
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
n=6 Participants
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 Participants
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.1 months
STANDARD_DEVIATION 5.49 • n=37 Participants
|
15.8 months
STANDARD_DEVIATION 5.34 • n=56 Participants
|
18.5 months
STANDARD_DEVIATION 4.97 • n=82 Participants
|
17.1 months
STANDARD_DEVIATION 5.27 • n=31 Participants
|
|
Age, Customized
6 - <12 months
|
1 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
3 Participants
n=31 Participants
|
|
Age, Customized
12 - 24 months
|
6 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
5 Participants
n=82 Participants
|
16 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
5 Participants
n=82 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=37 Participants
|
5 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
11 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
8 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
2 Participants
n=56 Participants
|
4 Participants
n=82 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
2 Participants
n=82 Participants
|
12 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The ITT population was used for all efficacy and baseline analyses.
An SBM is defined as a BM that occurs in the absence of laxative, enema, or suppository use on the calendar day of the BM or the calendar day before the BM. The caregiver/parent/guardian/legally authorized representative (LAR) will complete the electronic diary (eDiary), providing data for the SBM frequency rate up to the last dose date equivalent to the 4-week SBM frequency rate.
Outcome measures
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
n=7 Participants
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
n=6 Participants
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 Participants
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period
Observed by the LAR/Parent/Guardian/Caregiver
|
3.181 SBMs/Week
Standard Deviation 0.9563
|
2.503 SBMs/Week
Standard Deviation 1.3791
|
0.246 SBMs/Week
Standard Deviation 0.7035
|
|
Change From Baseline in Overall Spontaneous Bowel Movement (SBM) Frequency Rate (SBMs/Week) During the Study Intervention Period
All Reported by the LAR/Parent/Guardian/Caregiver
|
3.371 SBMs/Week
Standard Deviation 0.9858
|
2.577 SBMs/Week
Standard Deviation 1.4293
|
0.895 SBMs/Week
Standard Deviation 1.1475
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The ITT population was used for all efficacy and baseline analyses.
The caregiver/parent/guardian/legally authorized representative (LAR) will rate and record in an eDiary the consistency of the stool for each BM using the Bristol Stool Form 7-point scale in which 1=Separate hard lumps, like nuts (hard to pass); 2=Sausage-shaped, but lumpy; 3=Like a sausage but with cracks on its surface; 4=Like a sausage or snake, smooth and soft; 5=Soft blobs with clear cut edges (easy to pass); 6=Fluffy pieces with ragged edges, a mushy stool; and 7=Watery, no solid pieces, entirely liquid.
Outcome measures
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
n=7 Participants
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
n=6 Participants
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 Participants
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Change From Baseline in Stool Consistency (Bristol Stool Form Scale) During the Study Intervention Period
|
0.845 units on a scale
Standard Deviation 2.1137
|
1.062 units on a scale
Standard Deviation 0.8043
|
1.201 units on a scale
Standard Deviation 1.0192
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: The ITT population was used for all efficacy and baseline analyses.
Straining for each LAR/parent/guardian/caregiver-observed BM the child passes was collected daily in the eDiary device, using a 4-point scale (0 = No, not at all; 1 = Yes, a little; 2 = Yes, a lot; 3 = I don't know) based on two questions (did he/she grunt or make a face like he/she was straining). Lower value represents a better outcome and "I don't know" is considered as a missing response. The subject's average straining score for each caregiver-observed BM was derived based on the average of non-missing responses of the two straining questions. The participant's straining score in the 4-week Study Intervention Period was the average of the non-missing average straining scores from all caregiver-observed SBMs during the 4-week Study Intervention Period. If a subject had no caregiver-observed SBMs at baseline, then the baseline straining score reported by the caregiver was missing and, therefore, that subject was not included in the change from baseline straining analysis.
Outcome measures
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
n=7 Participants
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
n=6 Participants
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 Participants
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Change From Baseline in Straining During the Study Intervention Period
|
-1.087 score on a scale
Standard Deviation 0.6511
|
-0.821 score on a scale
Standard Deviation 0.9659
|
-0.561 score on a scale
Standard Deviation 0.3779
|
PRIMARY outcome
Timeframe: Up to Week 5Population: The SA analysis population was used for safety analyses.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Outcome measures
| Measure |
Open-Label Linaclotide 9 µg (Part 1)
n=7 Participants
Linaclotide capsules, mixed with water (or apple juice or apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
Double-Blind Placebo (Part 2)
n=6 Participants
Participants will receive placebo capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 Participants
Participants will receive Linaclotide capsules mixed with water (or apple juice or apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
3 participants
|
1 participants
|
3 participants
|
Adverse Events
Double-Blind Placebo (Part 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Double-Blind Linaclotide 9 µg (Part 2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Open-Label Linaclotide 9 µg (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Double-Blind Placebo (Part 2)
n=6 participants at risk
Participants will receive placebo capsules mixed with water (or apple juice/apple sauce) and administered orally in Part 2 for 4 weeks.
Placebo: Capsule; oral
|
Double-Blind Linaclotide 9 µg (Part 2)
n=6 participants at risk
Participants will receive Linaclotide capsules mixed with water (or apple juice/apple sauce) and administered orally in Part 2 for 4 weeks.
Linaclotide: Capsule; oral
|
Open-Label Linaclotide 9 µg (Part 1)
n=7 participants at risk
Linaclotide capsules, mixed with water (or apple juice/apple sauce) and administered orally, once daily for 4 weeks in Part 1.
Linaclotide: Capsule; oral
|
|---|---|---|---|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
28.6%
2/7 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Infections and infestations
CONJUNCTIVITIS VIRAL
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
14.3%
1/7 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
14.3%
1/7 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/6 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
0.00%
0/7 • All-cause mortality and adverse event tables include events reported from the time of informed consent to the end of the study. The median time on follow-up was 72.5, 76.5, and 77 days for Double-Blind Placebo, Double-Blind Linaclotide 9 µg (Part 2), and Open-Label Linaclotide 9 µg (Part 1), respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place