GVHD
Conditions
Keywords
Graft versus host disease, GVHD, GVHD, Acute, Steroid-refractory aGVHD, Gastrointestinal-GVHD, GI-GVHD
Brief summary
The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal aGVHD.
Detailed description
This is an international, multicenter, randomized proof-of-concept trial to evaluate safety, tolerability, efficacy, durability of response, and clinical outcomes of apraglutide administration to subjects with steroid-refractory (SR) aGVHD of the lower GI tract being treated with systemic steroids (SS) and ruxolitinib (RUX).
Interventions
DRUGApraglutide
Apraglutide is a new, synthetic glucagon-like peptide 2 (GLP-2) receptor agonist which acts as a gut targeted regenerative approach that is intestinotrophic with a mode of action that improves absorption and enhances gut barrier function.
Sponsors
VectivBio AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to give informed consent and agree to follow the details of participation as outlined in the protocol * Male or female subjects aged 12 years or above at the time of consent and who weigh a minimum of 40 kg. Only subjects aged 18 years and above will be included in Germany. * Clinically confirmed steroid refractory lower GI-aGVHD (MAGIC stage 1-4) prior to randomization * Have undergone alloSCT from any donor source, any conditioning regimen * Treated with SS plus RUX (RUX starts concomitantly to apraglutide or a maximum of 72 hours before apraglutide initiation) * Women of childbearing potential (WOCBP): highly effective method of contraception and refrain from donating eggs during the trial and for 4 weeks after the End of Trial (EOT) visit * Male subjects with partner WOCBP: contraception and abstention from sperm donation during the trial and for 2 weeks after the EOT visit
Exclusion criteria
* Treatment with any systemic GVHD therapy other than SS and RUX including methotrexate and mycophenolate mofetil at the time of randomization / Day 0 * Concomitant treatment with Janus kinase inhibitor other than RUX at the time of randomization * Failed alloSCT due to relapse of underlying malignant disease * Presence of SR GI-aGVHD occurring after donor lymphocyte infusion for pre-emptive treatment of malignancy recurrence * Any use of enteral glutamine or GLP analogs or known ADA, within 6 months prior to randomization / Day 0 * Significant organ system failures (respiratory renal hepatic and cardiac) * Presence of relapsed primary malignancy or treatment for relapse after alloHSCT * Presence or history of GI tumors (including the hepatobiliary system and pancreas) within the last five years before randomization * Presence of colonic polyps not removed * Active clinically uncontrolled infection or active tuberculosis * Known chronic GVHD * Known active GI inflammation not related to GI-aGVHD * Major abdominal surgery in the last 6-months prior to randomization or history of clinically significant intestinal adhesions * Abnormal liver function tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks | 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). |
| Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks | 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 |
| Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial | 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. |
| Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF) | Baseline, Weeks 26, 52, 104/End of Trial | 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. |
| Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial | 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. |
| Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | 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 Trial | 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. |
| Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial | 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. |
| Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial | — |
| Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | Baseline (BL), up to Week 104/End of Treatment | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91 | From first injection of apraglutide up to Day 91 | 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.) |
| Failure-Free Survival Post-First Dose of Apraglutide | Baseline up to 2 years | 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. |
| Time to Non-Relapse Mortality up to 2 Years Post Treatment Start | From first dose of apraglutide up to 2 years | Non-relapse mortality is defined as time from first dose until death without preceding hematologic relapse. |
| Overall Survival | Baseline up to 2 years post-first dose of apraglutide | Overall survival is calculated as the time from first dose of apgraglutide to death. |
| Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage | Day 56 | 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. |
| Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide | From first dose of apraglutide up to 2 years post-first dose | 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% |
| Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR | From first apraglutide dose up to Day 182 | 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). |
| Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide | From start of the RUX treatment up to Day 91 after the first dose of apraglutide | 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. |
| Number of Participants With Treatment-Emergent Infections and Sepsis | From baseline to Day 91 and overall (up to 2 years after the first dose of apraglutide) | — |
| Percentage of Participants With Hematologic Malignancy Relapse/Progression | Baseline to 2 years | — |
| Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Days 14, 28, 56, 91, 119, 147, and 182 | 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. |
| Overall Response Rate Over Time on the Total MAGIC Stage | Days 14, 28, 56, 91, 119, 147, and 182 | 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. |
| Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56 | Day 28 to Day 56 | 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.) |
| Duration of Response From Day 56 on the Total MAGIC Score | From Day 56 up to 2 years of follow up after the first dose | 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. |
| Duration of Response From Day 28 on the Total MAGIC Score | From Day 28 up to 2 years of follow up after the first dose | 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. |
| Duration of Lower GI Response Per MAGIC Score | Up to Day 147 | 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. |
| Duration of Lower GI Response Per MAGIC Score In Retreated Participants | Up to Day 147 | 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. |
| Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | From first injection of apraglutide up to Day 57 | 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. |
Countries
Germany, Portugal, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| 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. | 15 |
| 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. | 1 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 |
| Overall Study | Death | 3 | 6 | 1 |
| Overall Study | Physician Decision due to Non-Compliance | 1 | 0 | 0 |
| Overall Study | Pregnancy | 5 | 2 | 0 |
| Overall Study | Trial Terminated by Sponsor | 1 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Apraglutide Low Dose | Apraglutide High Dose | Apraglutide Standard Dose | Total |
|---|---|---|---|---|
| Age, Continuous | 58.9 years STANDARD_DEVIATION 9 | 62.0 years STANDARD_DEVIATION 9.68 | 52.0 years | 60.2 years STANDARD_DEVIATION 9.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 15 Participants | 1 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 14 Participants | 1 Participants | 29 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 1 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 8 Participants | 0 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 15 | 6 / 15 | 1 / 1 |
| other Total, other adverse events | 15 / 15 | 15 / 15 | 1 / 1 |
| serious Total, serious adverse events | 6 / 15 | 15 / 15 | 1 / 1 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
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).
Time frame: Screening (up to 12 weeks) through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 3 | 10 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 1 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 2 | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 3 | 4 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 4 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 5 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: >= Grade 3 | 4 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AE Leading to Death | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Serious Pre-Treatment AEs | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs | 15 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 1 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 2 | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs | 5 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 4 | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 5 | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs >= Grade 3 | 13 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAE Leading to Death | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs | 5 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 1 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 2 | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 3 | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 4 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 5 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs >= Grade 3 | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Serious TEAEs | 6 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious TEAEs | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Reduction | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Interruption | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Permanent Discontinuation of Apraglutide | 5 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Meeting Trial Stopping Criteria | 5 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Discontinuation from Trial | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs | 10 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 1 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 2 | 4 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 3 | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 4 | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 5 | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs >= Grade 3 | 6 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Death | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 1 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 2 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 3 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 4 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 5 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs >= Grade 3 | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Serious Post-Treatment AEs | 6 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious Post-Treatment AEs | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Meeting Trial Stopping Criteria | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Discontinuation From Trial | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAE Leading to Death | 6 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Serious Post-Treatment AEs | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs | 4 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 1 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 2 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 3 | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 1 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 4 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 5 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs >= Grade 3 | 3 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 2 | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Serious TEAEs | 15 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious TEAEs | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious Post-Treatment AEs | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Reduction | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 3 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Interruption | 4 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Permanent Discontinuation of Apraglutide | 6 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Meeting Trial Stopping Criteria | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 4 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Discontinuation from Trial | 6 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs | 8 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Discontinuation From Trial | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 1 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 5 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 2 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs | 8 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 1 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 2 | 2 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 3 | 5 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 3 | 4 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 4 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Meeting Trial Stopping Criteria | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 5 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 4 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: >= Grade 3 | 5 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AE Leading to Death | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs >= Grade 3 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Serious Pre-Treatment AEs | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 5 | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs | 15 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 1 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 2 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs >= Grade 3 | 6 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 3 | 4 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 4 | 5 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 5 | 6 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Death | 1 Participants |
| Apraglutide High Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs >= Grade 3 | 15 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Serious Pre-Treatment AEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAE Leading to Death | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 2 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 4 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 1 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 1 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 2 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Serious Post-Treatment AEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 5 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 2 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 4 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 1 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 5 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs Grade 5 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Discontinuation From Trial | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Meeting Trial Stopping Criteria | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related TEAEs >= Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 3 | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Serious TEAEs | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 2 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 1 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious TEAEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 4 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs >= Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Reduction | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs >= Grade 3 | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: Grade 5 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Dose Interruption | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 2 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Permanent Discontinuation of Apraglutide | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Serious Post-Treatment AEs | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 5 | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Meeting Trial Stopping Criteria | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AEs: >= Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 4 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Leading to Discontinuation from Trial | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Drug-Related Post-Treatment AEs Grade 4 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Leading to Death | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Pre-Treatment AE Leading to Death | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any TEAEs Grade 3 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs Grade 1 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Adverse Events (AEs) | Any Post-Treatment AEs >= Grade 3 | 1 Participants |
Primary
Number of Participants With Anti-drug Antibodies (ADAs) Over Time
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Negative | 14 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Potentially Positive | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Screening = Negative | 4 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Negative | 10 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Potentially Positive | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Negative | 6 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Negative | 7 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Negative | 14 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Screening = Negative | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Potentially Positive | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Potentially Positive | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Screening = Negative | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Negative | 12 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Negative | 14 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Confirmation = Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Negative | 14 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Negative | 15 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Negative | 14 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Potentially Positive | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Negative | 14 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Negative | 11 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Potentially Positive | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Negative Immunodepletion | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Negative | 8 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Negative | 8 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Negative | 6 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Screening = Negative | 7 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 21 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Screening = Negative | 2 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Confirmation = Negative Immunodepletion | 2 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 52 : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | End of Treatment : Screening = Negative | 2 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | End of Treatment : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | End of Treatment : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | End of Treatment : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Screening = Negative | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Screening = Potentially Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 104/End of Trial : Confirmation = Positive | 0 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Negative | 14 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Potentially Positive | 1 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Negative Immunodepletion | 3 Participants |
| Apraglutide High Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 13 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 8 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 2 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 17 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Last Post-Baseline Value : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Potentially Positive | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Baseline : Confirmation = Negative Immunodepletion | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 4 : Screening = Negative | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Anti-drug Antibodies (ADAs) Over Time | Week 1 : Confirmation = Negative Immunodepletion | 0 Participants |
Primary
Number of Participants With Clinically Significant Changes From Baseline Over Time in QT Corrected for Heart Rate Using Fridericia's Formula (QTcF)
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.
Time frame: Baseline, Weeks 26, 52, 104/End of Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
Primary
Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs
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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : High | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 52 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 52 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 52 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Low | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : High | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Low | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Low | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 52 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 52 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 52 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Low | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : High | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Missing | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 52 : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 52 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 52 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : High | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : High | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : Low | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 21 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 26 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 21 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 26 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure End of Treatment : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure End of Treatment : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure End of Treatment : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Low | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 104/End of Trial : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate End of Treatment : High | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate End of Treatment : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : High | 2 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate End of Treatment : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 104/End of Trial : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 21 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Low | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 26 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure End of Treatment : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure End of Treatment : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure End of Treatment : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : High | 2 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 104 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Low | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : High | 0 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : High | 1 Participants |
| Apraglutide High Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 8 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 13 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 17 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 8 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 6 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 17 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 3 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 13 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 1 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 4 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Maximum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 2 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 8 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 4 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 1 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Week 6 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 6 : Low | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 3 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Diastolic Blood Pressure Week 2 : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Systolic Blood Pressure Minimum Post-Baseline Value : High | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Clinically Significant Changes From Baseline Over Time in Vital Signs | Heart Rate Week 4 : High | 0 Participants |
Primary
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 | 1 Participants |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 1 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 1 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
Primary
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases
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.
Time frame: Baseline, Weeks 1, 2, 3, 4, 6, 8, 13, 17, 21, 26, 52, End of Treatment (up to Week 25), Week 104/End of Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 4 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 17 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 52 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 6 : Missing | 1 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 13 : Missing | 1 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 8 : Missing | 1 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 2 : Missing | 1 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 26 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Baseline : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 3 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 21 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 1 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Baseline : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 1 : Missing | 2 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | 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 | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 3 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 4 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 6 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 8 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 13 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 17 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 21 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 26 : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 17 : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 1 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 3 : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 8 : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Baseline : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 6 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 2 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 13 : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Potential Hy's Law Cases | Week 4 : Missing | 0 Participants |
Primary
Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin
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.
Time frame: 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 Trial
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 21 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : Missing | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : >= 2 x ULN | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : Missing | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 9 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 9 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 104/End of Trial : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 10 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 10 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 11 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 11 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 12 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 12 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 52 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 52 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 26 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : >= 2 x ULN | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 26 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Baseline : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : >= 2 x ULN | 1 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 21 : Missing | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : >= 2 x ULN | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 23 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Baseline : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : >= 2 x ULN | 1 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 9 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 9 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 10 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 10 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 11 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 11 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 12 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 12 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 14 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 15 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 15 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 16 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 16 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 18 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 18 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 19 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 19 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 20 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 20 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 21 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 21 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 22 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 22 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 23 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 24 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 24 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 25 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 25 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 26 : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 26 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | End of Treatment : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | End of Treatment : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 104/End of Trial : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Minimum Post-Baseline Value : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | 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 |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Last Post-Baseline Value : >= 2 x ULN | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : Missing | 0 Participants |
| Apraglutide High Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 14 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Baseline : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 13 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Minimum Post-Baseline Value : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 15 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Last Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 15 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Minimum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 8 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 5 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 17 : Missing | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 18 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 18 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 4 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 19 : >= 2 x ULN | 1 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 19 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 1 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 7 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | 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 |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 6 : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 3 : >= 2 x ULN | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Maximum Post-Baseline Value : Missing | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Potentially Clinically Significant Values Over Time in Liver Function Tests: Total Bilirubin | Week 2 : Missing | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs)
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
Time frame: From first dose of study drug through End of Trial (up to 2 years/104 weeks) for a total of up to 116 weeks
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Fluid Overload | 2 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Injection Site Reactions | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Colorectal Polyps | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gastrointestinal Obstructions | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Systemic Hypersensitivity | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Newly Diagnosed Malignancy | 0 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gall Bladder, Biliary and Pancreatic Disease | 0 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Colorectal Polyps | 0 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gastrointestinal Obstructions | 4 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Fluid Overload | 2 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gall Bladder, Biliary and Pancreatic Disease | 1 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Injection Site Reactions | 0 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Newly Diagnosed Malignancy | 0 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Systemic Hypersensitivity | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Injection Site Reactions | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Fluid Overload | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Systemic Hypersensitivity | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Newly Diagnosed Malignancy | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Colorectal Polyps | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gall Bladder, Biliary and Pancreatic Disease | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Adverse Events of Special Interest (AESIs) | Gastrointestinal Obstructions | 0 Participants |
Primary
Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations
Time frame: Baseline (BL), up to Week 104/End of Treatment
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide. Participants with an assessment at given time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, clinically significant (CS) : WPT Abnormal, CS | 4 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, CS : WPT Normal | 0 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Abnormal, CS | 3 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Abnormal, NCS | 4 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Normal | 1 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Abnormal, CS | 1 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Abnormal, NCS | 2 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Normal | 0 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Missing : WPT Abnormal, CS | 0 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Missing : WPT Abnormal, NCS | 0 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Missing : WPT Normal | 0 Participants |
| Apraglutide Low Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, CS : WPT Abnormal, Not Clinically Significant (NCS) | 0 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, clinically significant (CS) : WPT Abnormal, CS | 3 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, CS : WPT Abnormal, Not Clinically Significant (NCS) | 0 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Abnormal, NCS | 3 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Missing : WPT Abnormal, NCS | 1 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Abnormal, CS | 1 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Missing : WPT Abnormal, CS | 0 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Abnormal, CS | 5 Participants |
| Apraglutide High Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Abnormal, NCS | 2 Participants |
| Apraglutide Standard Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Normal : WPT Abnormal, CS | 0 Participants |
| Apraglutide Standard Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, NCS : WPT Abnormal, CS | 1 Participants |
| Apraglutide Standard Dose | Shift Table From Baseline to Worst Post-Treatment (WPT) Physical Examinations | BL Abnormal, clinically significant (CS) : WPT Abnormal, CS | 0 Participants |
Secondary
Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91
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.)
Time frame: From first injection of apraglutide up to Day 91
Population: Full Analysis Set: All enrolled participants with a response and an assessment at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | 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 | 40.0 percentage of participants |
| Apraglutide High Dose | Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91 | Best Overall Lower GI Response = CR | 53.3 percentage of participants |
| Apraglutide High Dose | 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 | 53.3 percentage of participants |
| Apraglutide High Dose | Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91 | Best Overall Lower GI Response = PR | 33.3 percentage of participants |
| Apraglutide Standard Dose | 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 | 0 percentage of participants |
| Apraglutide Standard Dose | Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91 | Best Overall Lower GI Response = PR | 0 percentage of participants |
| Apraglutide Standard Dose | 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 | 100 percentage of participants |
| Apraglutide Standard Dose | Best Overall Lower GI Response and Total Response at Any Time Point Up to and Including Day 91 | Best Overall Lower GI Response = CR | 100 percentage of participants |
Secondary
Cumulative Ruxolitinib (RUX) and Systemic Steroid (SS) Doses From Start of the RUX Treatment up to Day 91 After the First Dose of Apraglutide
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.
Time frame: From start of the RUX treatment up to Day 91 after the first dose of apraglutide
Population: Safety Analysis Set: All the randomized participants exposed to at least 1 dose of apraglutide.Participant with an assessment at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 0.828 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 0.922 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 2.194 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | 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 | 1.049 mg/kg | Standard Deviation 0.907 |
| Apraglutide High Dose | 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 | 0.882 mg/kg | Standard Deviation 0.6197 |
| Apraglutide High Dose | 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 | 1.114 mg/kg | Standard Deviation 0.8958 |
| Apraglutide High Dose | 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 | 1.114 mg/kg | Standard Deviation 0.8958 |
| Apraglutide High Dose | 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 | 0.945 mg/kg | Standard Deviation 0.7223 |
| Apraglutide High Dose | 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 | 1.033 mg/kg | Standard Deviation 0.7451 |
| Apraglutide High Dose | 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 | 0.988 mg/kg | Standard Deviation 0.5212 |
| Apraglutide High Dose | 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 | 1.049 mg/kg | Standard Deviation 0.7397 |
| Apraglutide High Dose | 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 | 9.482 mg/kg | Standard Deviation 4.2267 |
| Apraglutide High Dose | 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 | 5.543 mg/kg | Standard Deviation 3.9627 |
| Apraglutide High Dose | 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 | 0.988 mg/kg | Standard Deviation 0.8091 |
| Apraglutide High Dose | 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 | 3.938 mg/kg | Standard Deviation 2.6529 |
| Apraglutide High Dose | 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 | 2.864 mg/kg | Standard Deviation 2.4736 |
| Apraglutide High Dose | 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 | 2.057 mg/kg | Standard Deviation 1.4276 |
| Apraglutide High Dose | 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 | 1.580 mg/kg | Standard Deviation 0.449 |
| Apraglutide High Dose | 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 | 1.369 mg/kg | Standard Deviation 0.6378 |
| Apraglutide High Dose | 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 | 0.800 mg/kg | Standard Deviation 0.7199 |
| Apraglutide High Dose | 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 | 1.212 mg/kg | Standard Deviation 0.7907 |
| Apraglutide High Dose | 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 | 1.687 mg/kg | Standard Deviation 1.6041 |
| Apraglutide High Dose | 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 | 1.020 mg/kg | Standard Deviation 0.8496 |
| Apraglutide High Dose | 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 | 0.911 mg/kg | Standard Deviation 0.801 |
| Apraglutide High Dose | 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 | 0.927 mg/kg | Standard Deviation 0.9531 |
| Apraglutide High Dose | 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 | 1.026 mg/kg | Standard Deviation 0.8366 |
| Apraglutide High Dose | 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 | 1.062 mg/kg | Standard Deviation 0.8769 |
| Apraglutide High Dose | 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 | 1.038 mg/kg | Standard Deviation 0.8778 |
| Apraglutide High Dose | 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 | 1.021 mg/kg | Standard Deviation 0.6495 |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 2.581 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.935 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 6.022 mg/kg | — |
| Apraglutide Standard Dose | 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 | 9.892 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 5.419 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 0.968 mg/kg | — |
| Apraglutide Standard Dose | 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 | 6.366 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 5.849 mg/kg | — |
| Apraglutide Standard Dose | 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 | 2.796 mg/kg | — |
| Apraglutide Standard Dose | 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 | 15.484 mg/kg | — |
| Apraglutide Standard Dose | 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 | 6.882 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 13.118 mg/kg | — |
| Apraglutide Standard Dose | 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 | 1.505 mg/kg | — |
| Apraglutide Standard Dose | 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 | 3.011 mg/kg | — |
| Apraglutide Standard Dose | 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 | 11.398 mg/kg | — |
| Apraglutide Standard Dose | 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 | 5.419 mg/kg | — |
| Apraglutide Standard Dose | 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 | 8.430 mg/kg | — |
| Apraglutide Standard Dose | 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 | 9.032 mg/kg | — |
| Apraglutide Standard Dose | 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 | 8.430 mg/kg | — |
Secondary
Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56
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.)
Time frame: Day 28 to Day 56
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56 | Lower GI MAGIC Score | 33.3 percentage of participants |
| Apraglutide High Dose | Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56 | Total MAGIC Score | 33.3 percentage of participants |
| Apraglutide Standard Dose | Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56 | Lower GI MAGIC Score | 100 percentage of participants |
| Apraglutide Standard Dose | Durable Overall Response Rates on the Lower GI and Total MAGIC Score From Day 28 to Day 56 | Total MAGIC Score | 100 percentage of participants |
Secondary
Duration of Lower GI Response Per 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.
Time frame: Up to Day 147
Population: Full Analysis Set: all enrolled participants. Participants with best response of CR or PR on the Lower GI MAGIC Score.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Duration of Lower GI Response Per MAGIC Score | 58.0 days |
| Apraglutide High Dose | Duration of Lower GI Response Per MAGIC Score | 22.0 days |
| Apraglutide Standard Dose | Duration of Lower GI Response Per MAGIC Score | 113.0 days |
Secondary
Duration of Lower GI Response Per MAGIC Score In Retreated Participants
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.
Time frame: Up to Day 147
Population: Full Analysis Set: all enrolled participants. Participants who were re-treated with apraglutide because of a lower GI-aGVHD flare.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apraglutide Standard Dose | Duration of Lower GI Response Per MAGIC Score In Retreated Participants | NA days |
Secondary
Duration of Response From Day 28 on the Total MAGIC Score
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.
Time frame: From Day 28 up to 2 years of follow up after the first dose
Population: Full Analysis Set: all enrolled participants. Participants with best response of CR or PR on the Total MAGIC Score from Day 28.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Duration of Response From Day 28 on the Total MAGIC Score | 511.0 days |
| Apraglutide High Dose | Duration of Response From Day 28 on the Total MAGIC Score | NA days |
| Apraglutide Standard Dose | Duration of Response From Day 28 on the Total MAGIC Score | 92.0 days |
Secondary
Duration of Response From Day 56 on the Total MAGIC Score
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.
Time frame: From Day 56 up to 2 years of follow up after the first dose
Population: Full Analysis Set: all enrolled participants. Participants with a best response of CR or PR on the Total MAGIC Score from Day 56.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Duration of Response From Day 56 on the Total MAGIC Score | 483.0 days |
| Apraglutide High Dose | Duration of Response From Day 56 on the Total MAGIC Score | NA days |
| Apraglutide Standard Dose | Duration of Response From Day 56 on the Total MAGIC Score | 64.0 days |
Secondary
Failure-Free Survival Post-First Dose of Apraglutide
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.
Time frame: Baseline up to 2 years
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Failure-Free Survival Post-First Dose of Apraglutide | 539.0 days |
| Apraglutide High Dose | Failure-Free Survival Post-First Dose of Apraglutide | 103.0 days |
| Apraglutide Standard Dose | Failure-Free Survival Post-First Dose of Apraglutide | 121.0 days |
Secondary
Number of Participants With Treatment-Emergent Infections and Sepsis
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Infections | 8 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Sepsis | 3 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Infections | 8 Participants |
| Apraglutide Low Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Sepsis | 3 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Sepsis | 3 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Infections | 14 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Infections | 15 Participants |
| Apraglutide High Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Sepsis | 2 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Sepsis | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Sepsis | 0 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Study End : Infections | 1 Participants |
| Apraglutide Standard Dose | Number of Participants With Treatment-Emergent Infections and Sepsis | Between Baseline and Day 91 : Infections | 1 Participants |
Secondary
Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage
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.
Time frame: Day 56
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apraglutide Low Dose | Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage | 53.3 percentage of participants |
| Apraglutide High Dose | Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage | 46.7 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate at Day 56 on the Lower Gastrointestinal (GI) Tract Mount Sinai aGVHD International Consortium (MAGIC) Stage | 100 percentage of participants |
Secondary
Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage
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.
Time frame: Days 14, 28, 56, 91, 119, 147, and 182
Population: Full Analysis Set: all enrolled participants.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 28 | 66.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 119 | 40.0 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 91 | 46.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 14 | 53.3 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 182 | 26.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 147 | 26.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 56 | 53.3 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 91 | 46.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 14 | 66.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 28 | 40.0 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 56 | 46.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 119 | 40.0 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 147 | 40.0 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 182 | 40.0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 119 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 28 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 182 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 147 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 91 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 56 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Lower GI Tract MAGIC Stage | Day 14 | 100 percentage of participants |
Secondary
Overall Response Rate Over Time on the Total MAGIC Stage
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.
Time frame: Days 14, 28, 56, 91, 119, 147, and 182
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 28 | 66.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 119 | 33.3 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 91 | 40.0 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 14 | 53.3 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 182 | 26.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 147 | 26.7 percentage of participants |
| Apraglutide Low Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 56 | 53.3 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 91 | 46.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 14 | 53.3 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 28 | 46.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 56 | 46.7 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 119 | 40.0 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 147 | 40.0 percentage of participants |
| Apraglutide High Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 182 | 40.0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 119 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 28 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 182 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 147 | 0 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 91 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 56 | 100 percentage of participants |
| Apraglutide Standard Dose | Overall Response Rate Over Time on the Total MAGIC Stage | Day 14 | 100 percentage of participants |
Secondary
Overall Survival
Overall survival is calculated as the time from first dose of apgraglutide to death.
Time frame: Baseline up to 2 years post-first dose of apraglutide
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Overall Survival | NA days |
| Apraglutide High Dose | Overall Survival | 169.0 days |
| Apraglutide Standard Dose | Overall Survival | 175.0 days |
Secondary
Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR
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).
Time frame: From first apraglutide dose up to Day 182
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apraglutide Low Dose | Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR | 0 percentage of participants |
| Apraglutide High Dose | Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR | 0 percentage of participants |
| Apraglutide Standard Dose | Percentage of Participants Who Experienced Lower-GI Flare by Day 182 After Earlier Cessation of Treatment Due to CR | 100 percentage of participants |
Secondary
Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide
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%
Time frame: From first dose of apraglutide up to 2 years post-first dose
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apraglutide Low Dose | Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide | 0 percentage of participants |
| Apraglutide High Dose | Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide | 6.7 percentage of participants |
| Apraglutide Standard Dose | Percentage of Participants With Graft Failure Up to 2 Years Post-first Dose of Apraglutide | 0 percentage of participants |
Secondary
Percentage of Participants With Hematologic Malignancy Relapse/Progression
Time frame: Baseline to 2 years
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apraglutide Low Dose | Percentage of Participants With Hematologic Malignancy Relapse/Progression | 6.7 percentage of participants |
| Apraglutide High Dose | Percentage of Participants With Hematologic Malignancy Relapse/Progression | 6.7 percentage of participants |
| Apraglutide Standard Dose | Percentage of Participants With Hematologic Malignancy Relapse/Progression | 0 percentage of participants |
Secondary
Time to Non-Relapse Mortality up to 2 Years Post Treatment Start
Non-relapse mortality is defined as time from first dose until death without preceding hematologic relapse.
Time frame: From first dose of apraglutide up to 2 years
Population: Full Analysis Set: all enrolled participants
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Apraglutide Low Dose | Time to Non-Relapse Mortality up to 2 Years Post Treatment Start | NA days |
| Apraglutide High Dose | Time to Non-Relapse Mortality up to 2 Years Post Treatment Start | NA days |
| Apraglutide Standard Dose | Time to Non-Relapse Mortality up to 2 Years Post Treatment Start | 175.0 days |
Secondary
Time to Partial or Complete Lower GI Response (PR or CR) 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.
Time frame: From first injection of apraglutide up to Day 57
Population: Full Analysis Set: all enrolled participants. Participants with a complete and/or partial lower GI response per MAGIC Score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide Low Dose | 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 |
| Apraglutide High Dose | Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | Time to Partial Lower GI Response | 22.9 days | Standard Deviation 15.64 |
| Apraglutide High Dose | Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | Time to Complete or Partial Lower GI Response | 16.6 days | Standard Deviation 10.6 |
| Apraglutide High Dose | Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | Time to Complete Lower GI Response | 23.8 days | Standard Deviation 18.61 |
| Apraglutide Standard Dose | Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | Time to Complete Lower GI Response | 9.0 days | — |
| Apraglutide Standard Dose | Time to Partial or Complete Lower GI Response (PR or CR) Per MAGIC Score | Time to Complete or Partial Lower GI Response | 9.0 days | — |