Trial Outcomes & Findings for Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD) (NCT NCT05415410)
NCT ID: NCT05415410
Last Updated: 2025-10-20
Results Overview
AE=any untoward medical occurrence which does not necessarily have a causal relationship with study drug. Serious AE (SAE)=any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study drug; is a clinically significant event in the Investigator's judgment. Treatment-emergent AE (TEAE)=AE with a start on or after the first administration of apraglutide (or present prior to the first dose of apraglutide but worsening in severity after starting treatment relative to the pre-treatment state) up to 28 days after the last dose of apraglutide. Pre-treatment AE=occurs after informed consent and before first dose; post-treatment AE=occurs after 28 days from last dose. AE are graded as follows: mild (1), moderate (2), severe (3), life-threatening (4), death (5).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
Results posted on
2025-10-20
Participant Flow
Participant milestones
| Measure |
Apraglutide Low Dose
Low-dose, weight-based apraglutide subcutaneous (SC) injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
1
|
Reasons for withdrawal
| Measure |
Apraglutide Low Dose
Low-dose, weight-based apraglutide subcutaneous (SC) injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Study
Death
|
3
|
6
|
1
|
|
Overall Study
Trial Terminated by Sponsor
|
1
|
5
|
0
|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Physician Decision due to Non-Compliance
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Pregnancy
|
5
|
2
|
0
|
Baseline Characteristics
Proof-of-concept Trial of Apraglutide in Acute Graft Versus Host Disease (aGVHD)
Baseline characteristics by cohort
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.9 years
STANDARD_DEVIATION 9.00 • n=5 Participants
|
62.0 years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
52.0 years
STANDARD_DEVIATION NA • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 9.28 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeksPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.
AE=any untoward medical occurrence which does not necessarily have a causal relationship with study drug. Serious AE (SAE)=any AE that: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in a neonate/infant born to a mother or father exposed to study drug; is a clinically significant event in the Investigator's judgment. Treatment-emergent AE (TEAE)=AE with a start on or after the first administration of apraglutide (or present prior to the first dose of apraglutide but worsening in severity after starting treatment relative to the pre-treatment state) up to 28 days after the last dose of apraglutide. Pre-treatment AE=occurs after informed consent and before first dose; post-treatment AE=occurs after 28 days from last dose. AE are graded as follows: mild (1), moderate (2), severe (3), life-threatening (4), death (5).
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs
|
5 Participants
|
8 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: Grade 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: Grade 3
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AEs: >= Grade 3
|
4 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Pre-Treatment AE Leading to Death
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious Pre-Treatment AEs
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs
|
15 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Grade 3
|
10 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Grade 4
|
1 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Grade 5
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs >= Grade 3
|
13 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE Leading to Death
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs Grade 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs Grade 3
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related TEAEs >= Grade 3
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious TEAEs
|
6 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Serious TEAEs
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Leading to Dose Reduction
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Leading to Dose Interruption
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Leading to Permanent Discontinuation of Apraglutide
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Meeting Trial Stopping Criteria
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAEs Leading to Discontinuation from Trial
|
3 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs
|
10 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Grade 3
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Grade 4
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Grade 5
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs >= Grade 3
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Leading to Death
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Post-Treatment AEs >= Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Serious Post-Treatment AEs
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Drug-Related Serious Post-Treatment AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Meeting Trial Stopping Criteria
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any Post-Treatment AEs Leading to Discontinuation From Trial
|
2 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeksPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.
An AESI (serious or non-serious) is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring, additional information, and rapid communication by the Investigator to the Sponsor is appropriate. AESIs include: * Injection site reactions * Gastrointestinal obstructions * Gallbladder, biliary, and pancreatic disease * Fluid overload * Colorectal polyps * Newly diagnosed malignancies * Systemic hypersensitivity
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Gastrointestinal Obstructions
|
3 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Fluid Overload
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Gall Bladder, Biliary and Pancreatic Disease
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Colorectal Polyps
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Injection Site Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Newly Diagnosed Malignancy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
Systemic Hypersensitivity
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Systolic Blood Pressure: * High is defined as \>= 160 mmHg AND \>=20 mmHg increase from baseline * Low is defined as \<= 90 mmHg AND \>=20 mmHg decrease from baseline Diastolic Blood Pressure: * High is defined as \>= 100 mmHg AND \>=15 mmHg increase from baseline * Low is defined as \<= 50 mmHg AND \>=15 mmHg decrease from baseline Heart Rate: * High is defined as \>= 120 bpm AND \>= 15 bpm increase from baseline * Low is defined as \<= 50 bpm AND \>= 15 bpm decrease from baseline Baseline is defined as the last measurement prior to the first dose of apraglutide. Minimum post-baseline is defined as the minimum measurement after the first dose of apraglutide. Maximum post-baseline is defined as the maximum measurement after the first dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 1 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 1 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 2 : High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 2 : Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 2 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 3 : High
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 3 : Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 4 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 4 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 6 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 6 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 8 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 8 : Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 13 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 13 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 13 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 17 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 17 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 21 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 21 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 26 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 26 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 52 : High
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 52 : Low
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure End of Treatment : High
|
—
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure End of Treatment : Low
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 104/End of Trial : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 104/End of Trial : Low
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Minimum Post-Baseline Value : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Minimum Post-Baseline Value : Low
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Maximum Post-Baseline Value : High
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Maximum Post-Baseline Value : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Last Post-Baseline Value : High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Last Post-Baseline Value : Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Systolic Blood Pressure Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 1 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 1 : Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 2 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 2 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 2 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 3 : High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 3 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 4 : High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 4 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 6 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 6 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 8 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 8 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 13 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 13 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 13 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 17 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 17 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 21 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 21 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 26 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 26 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 52 : High
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 52 : Low
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure End of Treatment : High
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure End of Treatment : Low
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 104 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 104 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Week 104 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Minimum Post-Baseline Value : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Minimum Post-Baseline Value : Low
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Maximum Post-Baseline Value : High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Maximum Post-Baseline Value : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Last Post-Baseline Value : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Last Post-Baseline Value : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Diastolic Blood Pressure Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 1 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 1 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 2 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 2 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 2 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 3 : High
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 3 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 4 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 4 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 6 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 6 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 8 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 8 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 13 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 13 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 13 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 17 : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 17 : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 17 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 21 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 21 : Low
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 26 : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 26 : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 52 : High
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 52 : Low
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate End of Treatment : High
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate End of Treatment : Low
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 104/End of Trial : High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 104/End of Trial : Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Minimum Post-Baseline Value : High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Minimum Post-Baseline Value : Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Maximum Post-Baseline Value : High
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Maximum Post-Baseline Value : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Last Post-Baseline Value : High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Last Post-Baseline Value : Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
Heart Rate Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 26, 52, 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Baseline is defined as the last measurement prior to the first dose of apraglutide. Minimum post-baseline is defined as the minimum measurement after the first dose of apraglutide. Maximum post-baseline is defined as the maximum measurement after the first dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=14 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=13 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : QTcF Interval > 450 - 480 msec
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : QTcF Interval > 480 - 500 msec
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : Increase from Baseline QTcF Interval > 30 - 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Baseline : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : QTcF Interval > 450 - 480 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : QTcF Interval > 480 - 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : Increase from Baseline QTcF Interval > 30 - 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : QTcF Interval > 450 - 480 msec
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : QTcF Interval > 480 - 500 msec
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : QTcF Interval > 500 msec
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : Increase from Baseline QTcF Interval > 30 - 60 msec
|
1 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : QTcF Interval > 450 - 480 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : QTcF Interval > 480 - 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : Increase from Baseline QTcF Interval > 30 - 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Week 104/End of Trial : Missing
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : QTcF Interval > 450 - 480 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : QTcF Interval > 480 - 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Minimum Post-Baseline Value : Missing
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : QTcF Interval > 450 - 480 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : QTcF Interval > 480 - 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Maximum Post-Baseline Value : Missing
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : QTcF Interval > 450 - 480 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : QTcF Interval > 480 - 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : QTcF Interval > 500 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 30 - 60 msec
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : Increase from Baseline QTcF Interval > 60 msec
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
Last Post-Baseline Value : Missing
|
0 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Baseline is defined as the last measurement prior to the first dose of apraglutide. Minimum post-baseline is defined as the minimum measurement after the first dose of apraglutide. Maximum post-baseline is defined as the maximum measurement after the first dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 17 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 17 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 17 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 13 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 13 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 17 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Baseline : >= 3 x upper limit of normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Baseline : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Baseline : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Baseline : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Baseline : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 1 : >= 3 x ULN
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 1 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 1 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 1 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 2 : >= 3 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 2 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 2 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 2 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 2 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 3 : >= 3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 3 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 3 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 3 : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 4 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 4 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 4 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 4 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 6 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 6 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 6 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 6 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 8 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 8 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 8 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 8 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 13 : >= 3 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 13 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 13 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 21 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 21 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 21 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 21 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 26 : >= 3 x ULN
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 26 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 26 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 26 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 52 : >= 3 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 52 : >= 5 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 52 : >= 10 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 52 : >= 20 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT End of Treatment : >= 3 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT End of Treatment : >= 5 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT End of Treatment : >= 10 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT End of Treatment : >= 20 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 104/End of Trial : >= 3 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 104/End of Trial : >= 5 x ULN
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 104/End of Trial : >= 10 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 104/End of Trial : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Minimum Post-Baseline Value : >= 3 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Minimum Post-Baseline Value : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Minimum Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Minimum Post-Baseline Value : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Maximum Post-Baseline Value : >= 3 x ULN
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Maximum Post-Baseline Value : >= 5 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Maximum Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Maximum Post-Baseline Value : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Last Post-Baseline Value : >= 3 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Last Post-Baseline Value : >= 5 x ULN
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Last Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Last Post-Baseline Value : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
ALT Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Baseline : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Baseline : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Baseline : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Baseline : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Baseline : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 1 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 1 : >= 5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 1 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 1 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 2 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 2 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 2 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 2 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 2 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 3 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 3 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 3 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 3 : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 4 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 4 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 4 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 4 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 6 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 6 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 6 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 6 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 8 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 8 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 8 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 8 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 13 : >= 3 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 13 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 13 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 13 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 13 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 17 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 17 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 17 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 17 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 21 : >= 3 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 21 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 21 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 21 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 26 : >= 3 x ULN
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 26 : >= 5 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 26 : >= 10 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 26 : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 52 : >= 3 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 52 : >= 5 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 52 : >= 10 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 52 : >= 20 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST End of Treatment : >= 3 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST End of Treatment : >= 5 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST End of Treatment : >= 10 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST End of Treatment : >= 20 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 104/End of Trial : >= 3 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 104/End of Trial : >= 5 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 104/End of Trial : >= 10 x ULN
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 104/End of Trial : >= 20 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Minimum Post-Baseline Value : >= 3 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Minimum Post-Baseline Value : >= 5 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Minimum Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Minimum Post-Baseline Value : >= 20 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Maximum Post-Baseline Value : >= 3 x ULN
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Maximum Post-Baseline Value : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Maximum Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Maximum Post-Baseline Value : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Last Post-Baseline Value : >= 3 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Last Post-Baseline Value : >= 5 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Last Post-Baseline Value : >= 10 x ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Last Post-Baseline Value : >= 20 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
AST Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 52, End of Treatment (up to Week 25), Week 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Baseline is defined as the last measurement prior to the first dose of apraglutide. Minimum post-baseline is defined as the minimum measurement after the first dose of apraglutide. Maximum post-baseline is defined as the maximum measurement after the first dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Baseline : >= 2 x Upper Limit of Normal (ULN)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Baseline : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 1 : >= 2 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 1 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 2 : >= 2 x ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 2 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 3 : >= 2 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 4 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 5 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 5 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 6 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 6 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 7 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 7 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 8 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 8 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 9 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 9 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 10 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 10 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 11 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 11 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 12 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 12 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 13 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 13 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 14 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 14 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 15 : >= 2 x ULN
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 15 : Missing
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 16 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 16 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 17 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 18 : >= 2 x ULN
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 18 : Missing
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 19 : >= 2 x ULN
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 19 : Missing
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 20 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 20 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 21 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 22 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 22 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 23 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 23 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 24 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 24 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 25 : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 25 : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 26 : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 52 : >= 2 x ULN
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
End of Treatment : >= 2 x ULN
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 104/End of Trial : >= 2 x ULN
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Minimum Post-Baseline Value : >= 2 x ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Minimum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Maximum Post-Baseline Value : >= 2 x ULN
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Maximum Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Last Post-Baseline Value : >= 2 x ULN
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
Last Post-Baseline Value : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Potential Hy's Law cases were defined as ALT or AST \>= 3 x ULN AND total bilirubin \>= 2 x ULN AND alkaline phosphatase (ALP) \<= 2 x ULN at the same visit. Baseline is defined as the last measurement prior to the first dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Baseline : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Baseline : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 1 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 1 : Missing
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 2 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 2 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 3 : Potential Hy's Law Cases
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 3 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 4 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 4 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 6 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 6 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 8 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 8 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 13 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 13 : Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 17 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 17 : Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 21 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 21 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 26 : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 26 : Missing
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 52 : Potential Hy's Law Cases
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 52 : Missing
|
0 Participants
|
—
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
End of Treatment : Potential Hy's Law Cases
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
End of Treatment : Missing
|
—
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 104/End of Trial : Potential Hy's Law Cases
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
Week 104/End of Trial : Missing
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of TrialPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Baseline : Screening = Negative
|
14 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Baseline : Screening = Potentially Positive
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Baseline : Confirmation = Negative Immunodepletion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Baseline : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Last Post-Baseline Value : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 1 : Screening = Negative
|
14 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 1 : Screening = Potentially Positive
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 1 : Confirmation = Negative Immunodepletion
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 1 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 2 : Screening = Negative
|
14 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 2 : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 2 : Confirmation = Negative Immunodepletion
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 2 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 4 : Screening = Negative
|
12 Participants
|
11 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 4 : Screening = Potentially Positive
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 4 : Confirmation = Negative Immunodepletion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 4 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 8 : Screening = Negative
|
10 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 8 : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 8 : Confirmation = Negative Immunodepletion
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 8 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 13 : Screening = Negative
|
7 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 13 : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 13 : Confirmation = Negative Immunodepletion
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 13 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 17 : Screening = Negative
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 17 : Screening = Potentially Positive
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 17 : Confirmation = Negative Immunodepletion
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 17 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 21 : Screening = Negative
|
4 Participants
|
7 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 21 : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 21 : Confirmation = Negative Immunodepletion
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 21 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 52 : Screening = Negative
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 52 : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 52 : Confirmation = Negative Immunodepletion
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 52 : Confirmation = Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
End of Treatment : Screening = Negative
|
—
|
2 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
End of Treatment : Screening = Potentially Positive
|
—
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
End of Treatment : Confirmation = Negative Immunodepletion
|
—
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
End of Treatment : Confirmation = Positive
|
—
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 104/End of Trial : Screening = Negative
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 104/End of Trial : Screening = Potentially Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 104/End of Trial : Confirmation = Negative Immunodepletion
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Week 104/End of Trial : Confirmation = Positive
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Last Post-Baseline Value : Screening = Negative
|
14 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Last Post-Baseline Value : Screening = Potentially Positive
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Last Post-Baseline Value : Confirmation = Negative Immunodepletion
|
1 Participants
|
3 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (BL), up to Week 104/End of TreatmentPopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
Outcome measures
| Measure |
Apraglutide Low Dose
n=8 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=9 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, clinically significant (CS) : WPT Abnormal, CS
|
4 Participants
|
3 Participants
|
0 Participants
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, NCS : WPT Normal
|
1 Participants
|
—
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Normal : WPT Abnormal, CS
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Normal : WPT Abnormal, NCS
|
2 Participants
|
2 Participants
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, CS : WPT Abnormal, Not Clinically Significant (NCS)
|
0 Participants
|
0 Participants
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, CS : WPT Normal
|
0 Participants
|
—
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, NCS : WPT Abnormal, CS
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Abnormal, NCS : WPT Abnormal, NCS
|
4 Participants
|
3 Participants
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Normal : WPT Normal
|
0 Participants
|
—
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Missing : WPT Abnormal, CS
|
0 Participants
|
0 Participants
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Missing : WPT Abnormal, NCS
|
0 Participants
|
1 Participants
|
—
|
|
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
BL Missing : WPT Normal
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 56Population: Full Analysis Set: all enrolled participants
Overall response rate at Day 56 on the lower GI tract MAGIC stage is defined as the percentage of participants with complete response (CR) or partial response (PR) on the lower GI tract MAGIC stage at Day 56. Lower GI (Stool Output/Day) MAGIC Stages are 0: \<500 mL/day or \<3/episodes/day; 1: 500-999 mL/day or 3-4/episodes/day; 2: 1000-1500 mL/day or 5-7/episodes/day; 3: \>1500 mL/day or \>7/episodes/day; 4: Severe abdominal pain with or without ileus or grossly bloody stool (regardless of volume). CR: Score of 0 in lower GI tract MAGIC stage that indicates complete resolution of all signs and symptoms of aGVHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. PR: Improvement of one stage in lower GI tract MAGIC stage without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response, or non-response of aGVHD.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage
|
53.3 percentage of participants
|
46.7 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Days 14, 28, 56, 91, 119, 147, and 182Population: Full Analysis Set: all enrolled participants.
Overall response rate on the lower GI tract MAGIC stage is defined as the percentage of participants with CR or PR on the lower GI tract MAGIC stage at given time points. Lower GI (Stool Output/Day) MAGIC Stages are 0: \<500 mL/day or \<3/episodes/day; 1: 500-999 mL/day or 3-4/episodes/day; 2: 1000-1500 mL/day or 5-7/episodes/day; 3: \>1500 mL/day or \>7/episodes/day; 4: Severe abdominal pain with or without ileus or grossly bloody stool (regardless of volume). CR: Score of 0 in lower GI tract MAGIC stage that indicates complete resolution of all signs and symptoms of aGVHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. PR: Improvement of one stage in lower GI tract MAGIC stage without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response, or non-response of aGVHD.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 14
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 28
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 56
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 91
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 119
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 147
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
Day 182
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Days 14, 28, 56, 91, 119, 147, and 182Population: Full Analysis Set: all enrolled participants
Overall response rate on Total MAGIC staging for each of the 4 evaluable organs of skin, lower and upper GI tract, and liver is defined as the percentage of participants with CR or PR on the total MAGIC stage. Staging values range from 0 to 4, with higher number indicating a worse state of disease. (For complete staging criteria, see: Harris AC, et al. Biol Blood Marrow Transplant. 2016;22(1):4-10.) CR: A score of 0 for the aGVHD grading in all evaluable organs that indicates complete resolution of all signs and symptoms of aGVHD in all 4 evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. PR: An improvement of one stage in one or more evaluable organs involved with aGVHD signs or symptoms without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response, or non-response of aGVHD.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 14
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 28
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 56
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 91
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
46.7 percentage of participants
Interval 21.3 to 73.4
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 119
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 147
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Overall Response Rate Over Time on the Total MAGIC Stage
Day 182
|
26.7 percentage of participants
Interval 7.8 to 55.1
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Day 28 to Day 56Population: Full Analysis Set: all enrolled participants
Durable overall response rate on the Lower GI MAGIC Score from Day 28 to Day 56 is defined as the percentage of participants who had a response (either CR responder or PR responder, see Outcome Measure 10 description for details) on the lower GI at Day 28 and remain a CR responder or PR responder on the lower GI at Day 56. Durable overall response rate from Day 28 to Day 56 on the Total MAGIC Score is defined as the percentage of participants who had a response (either CR responder or PR responder, see Outcome Measure 12 description for details) on the total MAGIC score at Day 28 and remain a CR responder or PR responder on the total MAGIC score at Day 56. Total MAGIC staging for each of the 4 evaluable organs of skin, lower and upper GI tract, and liver ranges from 0 to 4, with higher number indicating a worse state of disease. (For complete staging criteria, see: Harris AC, et al. Biol Blood Marrow Transplant. 2016;22(1):4-10.)
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56
Lower GI MAGIC Score
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56
Total MAGIC Score
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
100 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: From Day 56 up to 2 years of follow up after the first dosePopulation: Full Analysis Set: all enrolled participants. Participants with a best response of CR or PR on the Total MAGIC Score from Day 56.
Duration of response from Day 56 on the total MAGIC score: defined as the interval from the Day 56 response (PR and CR; see definitions descriptions in Outcome Measure 12) to death or new systemic therapy for aGVHD (including an increase in steroids \>2 mg/kg/day methylprednisolone \[MP\] equivalent), whichever occurs first, with at least 182 days of follow-up. Total MAGIC staging for each of the 4 evaluable organs of skin, lower and upper GI tract, and liver range from 0 to 4, with higher number indicating a worse state of disease. (For complete staging criteria, see: Harris AC, et al. Biol Blood Marrow Transplant. 2016;22(1):4-10.) Full range dates are censored. Censored = participants alive and without missing overall response assessment, initiation of additional systemic therapy for aGVHD or increase of \>2 mg/kg/day MP equivalent in steroids. Subjects are right censored at their last follow-up visit.
Outcome measures
| Measure |
Apraglutide Low Dose
n=8 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=7 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Duration of Response From Day 56 on the Total MAGIC Score
|
483.0 days
Interval 37.0 to 686.0
|
NA days
Interval 32.0 to 666.0
Not estimable due to low number of events.
|
64.0 days
Interval 64.0 to 64.0
|
SECONDARY outcome
Timeframe: From Day 28 up to 2 years of follow up after the first dosePopulation: Full Analysis Set: all enrolled participants. Participants with best response of CR or PR on the Total MAGIC Score from Day 28.
Duration of response from Day 28 on the total MAGIC score: defined as the interval from the Day 28 response (PR and CR; see definitions descriptions in Outcome Measure 12) to death or new systemic therapy for aGVHD (including an increase in steroids \>2 mg/kg/day methylprednisolone \[MP\] equivalent), whichever occurs first, with at least 182 days of follow-up. Total MAGIC staging for each of the 4 evaluable organs of skin, lower and upper GI tract, and liver range from 0 to 4, with higher number indicating a worse state of disease. (For complete staging criteria, see: Harris AC, et al. Biol Blood Marrow Transplant. 2016;22(1):4-10.) Full range dates are censored. Censored = participants alive and without missing overall response assessment, initiation of additional systemic therapy for aGVHD or increase of \>2 mg/kg/day MP equivalent in steroids. Subjects are right censored at their last follow-up visit.
Outcome measures
| Measure |
Apraglutide Low Dose
n=10 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=7 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Duration of Response From Day 28 on the Total MAGIC Score
|
511.0 days
Interval 13.0 to 714.0
|
NA days
Interval 12.0 to 694.0
Not estimable due to the low number of events.
|
92.0 days
Interval 92.0 to 92.0
|
SECONDARY outcome
Timeframe: Up to Day 147Population: Full Analysis Set: all enrolled participants. Participants with best response of CR or PR on the Lower GI MAGIC Score.
Individual duration of lower GI response (either CR responder or PR responder, see Outcome Measure 10 description for details) counted from the first response to return to baseline or worse. Duration of lower GI response is defined as the duration from the first date a participant is identified as a Lower GI MAGIC Score CR or PR responder until the next date a subject is Lower GI MAGIC Score stable disease/progressed disease (SD/PD; i.e., return to baseline or worsening), experiences treatment failure, or dies, whichever occurs first.
Outcome measures
| Measure |
Apraglutide Low Dose
n=13 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=13 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Duration of Lower GI Response Per MAGIC Score
|
58.0 days
Interval 1.0 to 729.0
|
22.0 days
Interval 1.0 to 358.0
|
113.0 days
Interval 113.0 to 113.0
|
SECONDARY outcome
Timeframe: Up to Day 147Population: Full Analysis Set: all enrolled participants. Participants who were re-treated with apraglutide because of a lower GI-aGVHD flare.
Individual duration of lower GI response (either CR responder or PR responder, see Outcome Measure 10 description for details) counted from the first response to return to baseline or worse in participants that were re-treated with apraglutide because of a lower GI-aGVHD flare, counted from the first response after apraglutide restart to return to baseline or worse. Duration of lower GI response is defined as the duration from the first date a participant is identified as a Lower GI MAGIC Score CR or PR responder until the next date a subject is Lower GI MAGIC Score stable disease/progressed disease (SD/PD; i.e., return to baseline or worsening), experiences treatment failure, or dies, whichever occurs first.
Outcome measures
| Measure |
Apraglutide Low Dose
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Duration of Lower GI Response Per MAGIC Score In Retreated Participants
|
—
|
—
|
NA days
Participant was re-treated but did not respond, therefore a duration of response for retreated participants could not be calculated.
|
SECONDARY outcome
Timeframe: From first injection of apraglutide up to Day 57Population: Full Analysis Set: all enrolled participants. Participants with a complete and/or partial lower GI response per MAGIC Score.
Lower GI (Stool Output/Day) MAGIC Stages are 0: \<500 mL/day or \<3/episodes/day; 1: 500-999 mL/day or 3-4/episodes/day; 2: 1000-1500 mL/day or 5-7/episodes/day; 3: \>1500 mL/day or \>7/episodes/day; 4: Severe abdominal pain with or without ileus or grossly bloody stool (regardless of volume). CR: Score of 0 in lower GI tract MAGIC stage that indicates complete resolution of all signs and symptoms of aGVHD in all evaluable organs without administration of additional systemic therapies for any earlier progression, mixed response or non-response of aGVHD. PR: Improvement of one stage in lower GI tract MAGIC stage without progression in other organs or sites without administration of additional systemic therapies for an earlier progression, mixed response, or non-response of aGVHD.
Outcome measures
| Measure |
Apraglutide Low Dose
n=13 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=13 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score
Time to Complete or Partial Lower GI Response
|
14.2 days
Standard Deviation 8.33
|
16.6 days
Standard Deviation 10.60
|
9.0 days
Standard Deviation NA
Only 1 participant in this arm.
|
|
Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score
Time to Partial Lower GI Response
|
14.0 days
Standard Deviation 7.72
|
22.9 days
Standard Deviation 15.64
|
—
|
|
Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score
Time to Complete Lower GI Response
|
41.9 days
Standard Deviation 31.24
|
23.8 days
Standard Deviation 18.61
|
9.0 days
Standard Deviation NA
Only 1 participant in this arm.
|
SECONDARY outcome
Timeframe: From first injection of apraglutide up to Day 91Population: Full Analysis Set: All enrolled participants with a response and an assessment at given time point.
Overall response rate on the Lower GI MAGIC Score is defined as the percentage of participants who had a response (either CR responder or PR responder, see Outcome Measure 10 description for details) on the lower GI score. Overall response rate on the Total MAGIC Score is defined as the percentage of participants who had a response (either CR responder or PR responder, see Outcome Measure 12 description for details) on the total MAGIC score. Best overall lower GI response and total response is defined as overall response (PR or CR) at any time point up to and including Day 91 and before the start of additional systemic therapy for lower GI aGVHD. MAGIC staging for each of the 4 evaluable organs of skin, lower and upper GI tract, and liver ranges from 0 to 4, with higher number indicating a worse state of disease. (For complete staging criteria, see: Harris AC, et al. Biol Blood Marrow Transplant. 2016;22(1):4-10.)
Outcome measures
| Measure |
Apraglutide Low Dose
n=13 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=13 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91
Best Overall Lower GI Response = CR
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91
Best Overall Lower GI Response = PR
|
20.0 percentage of participants
Interval 4.3 to 48.1
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
0 percentage of participants
Interval 0.0 to 97.5
|
|
Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91
Best Overall Response per Total MAGIC Score = CR
|
60.0 percentage of participants
Interval 32.3 to 83.7
|
53.3 percentage of participants
Interval 26.6 to 78.7
|
100 percentage of participants
Interval 2.5 to 100.0
|
|
Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91
Best Overall Response per Total MAGIC Score = PR
|
33.3 percentage of participants
Interval 11.8 to 61.6
|
40.0 percentage of participants
Interval 16.3 to 67.7
|
0 percentage of participants
Interval 0.0 to 97.5
|
SECONDARY outcome
Timeframe: Baseline up to 2 yearsPopulation: Full Analysis Set: all enrolled participants
Failure free survival is defined as time from first dose until death, hematologic malignancy relapse/progression, or treatment failure, whichever comes first. Treatment failure is reported when additional systemic therapies are used for any earlier progression, mixed response or stable aGVHD.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Failure-Free Survival Post-First Dose of Apraglutide
|
539.0 days
Interval 97.0 to
Not estimable due to the low number of events.
|
103.0 days
Interval 45.0 to
Not estimable due to the low number of events.
|
121.0 days
Only one participant in this arm.
|
SECONDARY outcome
Timeframe: From first dose of apraglutide up to 2 yearsPopulation: Full Analysis Set: all enrolled participants
Non-relapse mortality is defined as time from first dose until death without preceding hematologic relapse.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Time to Non-Relapse Mortality up to 2 Years Post Treatment Start
|
NA days
Interval 539.0 to
Not estimable due to the low number of events.
|
NA days
Interval 103.0 to
Not estimable due to the low number of events.
|
175.0 days
Only 1 participant in this arm.
|
SECONDARY outcome
Timeframe: Baseline up to 2 years post-first dose of apraglutidePopulation: Full Analysis Set: all enrolled participants
Overall survival is calculated as the time from first dose of apgraglutide to death.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Overall Survival
|
NA days
Interval 539.0 to
Not estimable due to the low number of events.
|
169.0 days
Interval 45.0 to
Not estimable due to the low number of events.
|
175.0 days
Only 1 participant in this arm.
|
SECONDARY outcome
Timeframe: Baseline to 2 yearsPopulation: Full Analysis Set: all enrolled participants
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Percentage of Participants With Hematologic Malignancy Relapse/Progression
|
6.7 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first dose of apraglutide up to 2 years post-first dosePopulation: Full Analysis Set: all enrolled participants
Primary graft failure: Absolute neutrophil count \< 0.5 × 10\^9/L by Day 28 Hemoglobin \<80 g/L and platelets \< 20 × 10\^9/L Reduced intensity conditioning: Confirmation of donor cell origin is required Cord blood transplant: Up to Day +42 Secondary graft failure: Absolute neutrophil count \< 0.5 × 10\^9/L after initial engraftment not related to relapse, infection, or drug toxicity Reduced intensity conditioning: Loss of donor hematopoiesis to \< 5%
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide
|
0 percentage of participants
|
6.7 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From first apraglutide dose up to Day 182Population: Full Analysis Set: all enrolled participants
Incidence of lower GI-aGVHD flare up to Day 182 after the first apraglutide dose following earlier cessation due to complete lower GI-aGVHD response. A lower GI-aGVHD flare is defined as any increase in signs or symptoms of lower GI-aGVHD that is sustained for \>24 hours after apraglutide treatment completion following a CR or PR in the lower GI (see Outcome Measure 10 description for details) and requires re-escalation of immunosuppressive therapy (e.g., corticosteroid, calcineurin inhibitors and/or ruxolitinib dosing).
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR
|
0 percentage of participants
Interval 0.0 to 21.8
|
0 percentage of participants
Interval 0.0 to 21.8
|
100 percentage of participants
Interval 2.5 to 100.0
|
SECONDARY outcome
Timeframe: From start of the RUX treatment up to Day 91 after the first dose of apraglutidePopulation: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.Participant with an assessment at given time point.
Concomitant treatment with any systemic GVHD therapy other than SS and RUX was prohibited. The exact dose of SS and RUX taken throughout the trial was recorded in the case report form, including any dose adjustments. Systemic steroid dose was computed using the converted systemic methylprednisolone equivalent dose.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Baseline - Day 7
|
1.724 mg/kg
Standard Deviation 0.6375
|
1.580 mg/kg
Standard Deviation 0.4490
|
1.935 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 7 - Day 14
|
1.714 mg/kg
Standard Deviation 0.5747
|
1.369 mg/kg
Standard Deviation 0.6378
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 14 - Day 21
|
1.444 mg/kg
Standard Deviation 0.8280
|
1.212 mg/kg
Standard Deviation 0.7907
|
2.796 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 21 - Day 28
|
1.549 mg/kg
Standard Deviation 0.8357
|
1.020 mg/kg
Standard Deviation 0.8496
|
3.011 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 28 - Day 35
|
1.523 mg/kg
Standard Deviation 0.8421
|
0.911 mg/kg
Standard Deviation 0.8010
|
2.581 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 35 - Day 42
|
1.355 mg/kg
Standard Deviation 0.9044
|
0.927 mg/kg
Standard Deviation 0.9531
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 42 - Day 49
|
1.357 mg/kg
Standard Deviation 0.9557
|
1.062 mg/kg
Standard Deviation 0.8769
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 49 - Day 56
|
1.308 mg/kg
Standard Deviation 0.9458
|
1.038 mg/kg
Standard Deviation 0.8778
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 56 - Day 63
|
1.185 mg/kg
Standard Deviation 0.8464
|
1.049 mg/kg
Standard Deviation 0.9070
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 63 - Day 70
|
1.204 mg/kg
Standard Deviation 0.9220
|
1.114 mg/kg
Standard Deviation 0.8958
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 70 - Day 77
|
1.169 mg/kg
Standard Deviation 0.7941
|
1.114 mg/kg
Standard Deviation 0.8958
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 77 - Day 84
|
1.162 mg/kg
Standard Deviation 0.7507
|
1.033 mg/kg
Standard Deviation 0.7451
|
0.968 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
RUX : Day 84 - Day 91
|
1.247 mg/kg
Standard Deviation 0.7381
|
1.049 mg/kg
Standard Deviation 0.7397
|
1.505 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Baseline - Day 7
|
7.951 mg/kg
Standard Deviation 4.6608
|
9.482 mg/kg
Standard Deviation 4.2267
|
15.484 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 7 - Day 14
|
5.931 mg/kg
Standard Deviation 4.5259
|
5.543 mg/kg
Standard Deviation 3.9627
|
13.118 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 14 - Day 21
|
4.924 mg/kg
Standard Deviation 3.9327
|
3.938 mg/kg
Standard Deviation 2.6529
|
11.398 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 21 - Day 28
|
3.661 mg/kg
Standard Deviation 3.3871
|
2.864 mg/kg
Standard Deviation 2.4736
|
9.032 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 28 - Day 35
|
3.066 mg/kg
Standard Deviation 2.9184
|
2.057 mg/kg
Standard Deviation 1.4276
|
9.892 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 35 - Day 42
|
2.675 mg/kg
Standard Deviation 2.7542
|
1.687 mg/kg
Standard Deviation 1.6041
|
8.430 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 42 - Day 49
|
2.124 mg/kg
Standard Deviation 2.2079
|
1.026 mg/kg
Standard Deviation 0.8366
|
6.366 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 49 - Day 56
|
1.681 mg/kg
Standard Deviation 2.1940
|
0.882 mg/kg
Standard Deviation 0.6197
|
6.022 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 56 - Day 63
|
1.586 mg/kg
Standard Deviation 1.1506
|
0.988 mg/kg
Standard Deviation 0.5212
|
5.849 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 63 - Day 70
|
1.069 mg/kg
Standard Deviation 0.8051
|
0.988 mg/kg
Standard Deviation 0.8091
|
5.419 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 70 - Day 77
|
1.802 mg/kg
Standard Deviation 2.1332
|
0.800 mg/kg
Standard Deviation 0.7199
|
5.419 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 77 - Day 84
|
1.422 mg/kg
Standard Deviation 2.0178
|
0.945 mg/kg
Standard Deviation 0.7223
|
6.882 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
|
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
SS : Day 84 - Day 91
|
1.353 mg/kg
Standard Deviation 1.8912
|
1.021 mg/kg
Standard Deviation 0.6495
|
8.430 mg/kg
Standard Deviation NA
Only 1 participant in this arm.
|
SECONDARY outcome
Timeframe: From baseline to Day 91 and overall (up to 2 years after the first dose of apraglutide)Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.
Outcome measures
| Measure |
Apraglutide Low Dose
n=15 Participants
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 Participants
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 Participants
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Infections and Sepsis
Between Baseline and Day 91 : Infections
|
8 Participants
|
14 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Infections and Sepsis
Between Baseline and Day 91 : Sepsis
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Infections and Sepsis
Between Baseline and Study End : Infections
|
8 Participants
|
15 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Infections and Sepsis
Between Baseline and Study End : Sepsis
|
3 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
Apraglutide Low Dose
Serious events: 6 serious events
Other events: 15 other events
Deaths: 3 deaths
Apraglutide High Dose
Serious events: 15 serious events
Other events: 15 other events
Deaths: 6 deaths
Apraglutide Standard Dose
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Apraglutide Low Dose
n=15 participants at risk
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 participants at risk
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 participants at risk
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Sepsis
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Bacteroides bacteraemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Candida infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Erysipelas
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Peritonitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Septic shock
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Vascular device infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Viral haemorrhagic cystitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Vulvitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Acute graft versus host disease
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Cytokine release syndrome
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Vascular disorders
Air embolism
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Vascular disorders
Hypovolaemic shock
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Post procedural infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
Other adverse events
| Measure |
Apraglutide Low Dose
n=15 participants at risk
Low-dose, weight-based apraglutide SC injections (1.4 to 3.5 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide High Dose
n=15 participants at risk
High-dose, weight-based apraglutide SC injections (3.5 to 7.6 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight of more than 50.0 kg.
|
Apraglutide Standard Dose
n=1 participants at risk
Standard-dose apraglutide SC injections (1.4 mg) once weekly for up to 13 weeks (with optional treatment up to an additional 13 weeks), for participants with body weight between 40.0 kg to 49.9 kg.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
6/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
53.3%
8/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
40.0%
6/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
46.7%
7/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Leukocytosis
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Oral candidiasis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
COVID-19
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Cystitis viral
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
BK virus infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Bacteraemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Enterococcal infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Infection
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Klebsiella bacteraemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Arthritis infective
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Cystitis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Erysipelas
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Escherichia urinary tract infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Herpes simplex
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Oesophageal infection
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Otitis media
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Paronychia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Polyomavirus viraemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Pyuria
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Staphylococcal bacteraemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Tracheobronchitis bacterial
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Tracheobronchitis mycoplasmal
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Infections and infestations
Vulvitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Oedema peripheral
|
46.7%
7/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
66.7%
10/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Fatigue
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Asthenia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Device related thrombosis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Generalised oedema
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Nodule
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Non-cardiac chest pain
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
General disorders
Thirst
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
33.3%
5/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Iron overload
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Folate deficiency
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Ileus
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Abdominal wall oedema
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Oesophageal pain
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Oral blood blister
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Tongue dry
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood creatinine increased
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Lipase increased
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Amylase increased
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
C-reactive protein increased
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Transaminases increased
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
BK polyomavirus test positive
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Blood fibrinogen decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Candida test positive
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Hepatic enzyme increased
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Pseudomonas test positive
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Investigations
Weight decreased
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Dysuria
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
26.7%
4/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone infarction
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Polyneuropathy
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Hypotonia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Migraine
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Hypogammaglobulinaemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Graft versus host disease oral
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Graft versus host disease in gastrointestinal tract
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Immune system disorders
Graft versus host disease in skin
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Cardiovascular disorder
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Sinus bradycardia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Depression
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Confusional state
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Dysphemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Hallucination
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
13.3%
2/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Eye disorders
Vision blurred
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Eye disorders
Ocular hypertension
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
20.0%
3/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Reproductive system and breast disorders
Perineal fistula
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Reproductive system and breast disorders
Vulva cyst
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal erythema
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
100.0%
1/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Hepatobiliary disorders
Hepatic failure
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Congenital, familial and genetic disorders
Phimosis
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
6.7%
1/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/15 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
0.00%
0/1 • Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
- Publication restrictions are in place
Restriction type: OTHER