Trial Outcomes & Findings for Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL (NCT NCT02564744)
NCT ID: NCT02564744
Last Updated: 2024-06-12
Results Overview
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included exacerbation of a pre-existing condition. AEs included worsening (change in nature, severity, or frequency) of conditions present at the onset of the study, intercurrent illnesses, drug interactions, events related to or possibly related to concomitant medications, abnormal laboratory values (this included significant shifts from baseline within the range of normal that the Investigator considered to be clinically important), clinically significant abnormalities in physical examination, vital signs, and weight.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Up to 30 days after end of treatment (EOT) (Up to 38 months)
Results posted on
2024-06-12
Participant Flow
The study was conducted at 38 investigative sites in the United States, Belgium, Ukraine, the Czech Republic, Hungary, Bulgaria, Italy, Poland, and Switzerland from 05 June 2016 to 25 June 2021.
A total of 127 participants were screened and 100 participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) and other forms of non-Hodgkin's lymphoma (NHL) were enrolled, 37 participants into Part 1 and 63 participants into Part 2/3.
Participant milestones
| Measure |
Part 1: Safety Run-in
Participants with a diagnosis of R/R DLBCL, and with NHL including follicular lymphoma (FL), marginal zone lymphoma/mucosa-associated lymphoid tissue (MZL/MALT), mantle cell lymphoma (MCL) or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, intravenous (IV) infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
8
|
12
|
33
|
30
|
|
Overall Study
Efficacy Evaluable (EE) Population
|
15
|
8
|
11
|
30
|
30
|
|
Overall Study
Pharmacokinetic (PK) Population
|
17
|
8
|
12
|
32
|
29
|
|
Overall Study
Anti-drug Antibody (ADA) Population
|
14
|
6
|
10
|
30
|
25
|
|
Overall Study
COMPLETED
|
5
|
1
|
4
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
8
|
19
|
20
|
Reasons for withdrawal
| Measure |
Part 1: Safety Run-in
Participants with a diagnosis of R/R DLBCL, and with NHL including follicular lymphoma (FL), marginal zone lymphoma/mucosa-associated lymphoid tissue (MZL/MALT), mantle cell lymphoma (MCL) or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, intravenous (IV) infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Overall Study
Investigator decision
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Death
|
10
|
5
|
4
|
16
|
16
|
|
Overall Study
End of study Page Missing
|
0
|
0
|
3
|
3
|
0
|
|
Overall Study
Subject Withdrew Consent
|
1
|
1
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Reason not specified
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL
Baseline characteristics by cohort
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 9.79 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 5.92 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 13.26 • n=4 Participants
|
68.7 years
STANDARD_DEVIATION 11.78 • n=21 Participants
|
67.8 years
STANDARD_DEVIATION 11.75 • n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
56 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
92 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
95 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after end of treatment (EOT) (Up to 38 months)Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included exacerbation of a pre-existing condition. AEs included worsening (change in nature, severity, or frequency) of conditions present at the onset of the study, intercurrent illnesses, drug interactions, events related to or possibly related to concomitant medications, abnormal laboratory values (this included significant shifts from baseline within the range of normal that the Investigator considered to be clinically important), clinically significant abnormalities in physical examination, vital signs, and weight.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
16 Participants
|
8 Participants
|
12 Participants
|
32 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after EOT (Up to 38 months)Population: Safety population includes all participants from the screened population who received at least one dose of Debio 1562.
The clinical laboratory tests included Hematology: Hematocrit (Hct), hemoglobin (Hgb), platelet count, red blood cell (RBC) count, white blood cell (WBC) count with differential; Serum Chemistry: Albumin (ALB), alkaline phosphatase (ALK-P), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), calcium (Ca), chloride (Cl), creatinine, glucose, lactate dehydrogenase (LDH), magnesium, phosphorus, potassium (K), sodium (Na), total bilirubin, total protein, uric acid, immunoglobulin levels (IgG, IgA, IgM); Urinalysis: Appearance, specific gravity and pH, evaluation of glucose, protein, bilirubin, ketones, leukocytes and blood; Coagulation: Prothrombin time (PT) or international normalized ratio (INR), activated partial thromboplastin time (aPTT).
Outcome measures
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Neutrophil Count Decreased
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Lymphocyte Count Decreased
|
5 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
WBC Count Decreased
|
5 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Platelet Count Decreased
|
4 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Anaemia
|
0 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Leukopenia
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Neutropenia
|
1 Participants
|
1 Participants
|
4 Participants
|
21 Participants
|
17 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Lymphopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypophosphataemia
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Thrombocytopenia
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Febrile Neutropenia
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
AST Increased
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
ALK-P Increased
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
ALT Increased
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Blood Creatinine Increased
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hemoglobin Decreased
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Blood Immunoglobulin G Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Blood Magnesium Decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hyperkalaemia
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypercalcaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hyperglycaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypernatraemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hyponatraemia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hyperphosphataemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hyperuricaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypoglycaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypomagnesaemia
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Blood Bilirubin Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Hypokalaemia
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs
Gamma-glutamyl transferase Increased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after EOT (Up to 38 months)Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.
A standard 12-lead ECG was performed.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
Atrial Fibrillation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs
Acute myocardial infarction
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after EOT (Up to 38 months)Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.
Vital signs included systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Body Temperature Increased
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Hypertension
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Hypotension
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Pyrexia
|
4 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Hyperthermia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs
Tachycardia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Progressive Disease (PD) or death (up to approximately 55 months) or initiation of new anti-cancer therapy whichever occurs firstPopulation: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).
ORR was defined as the percentage of participants with a Best overall response (BOR) of partial response (PR) or complete response (CR). BOR was the best response recorded from the start of the treatment until disease progression, initiation of new anti-cancer therapy, or end of the study period, whichever occurred first. CR was defined as disappearance of all target lesions, no new lesions formation. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤1.5 cm. PR was defined as ≥50% decrease in the sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=15 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=11 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
26.7 percent responders
Interval 7.8 to 55.1
|
12.5 percent responders
Interval 0.3 to 52.7
|
81.8 percent responders
Interval 48.2 to 97.7
|
50.0 percent responders
Interval 31.3 to 68.7
|
50.0 percent responders
Interval 31.3 to 68.7
|
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre and Post infusion: 5 min-Day (D) 1 of Cycles (C) 1-8 and 2 hours (h)-D1 of C1-2 (for Part 2/3), 24h-D2, 48h-D3 and D8, 15 of C1, 2; D1 of Month 37 (EOT) (rituximab only) and Month 38 (follow-up) (Cycle=21 days)Population: PK population included all participants who received at least one dose of Debio 1562 or rituximab and had atleast one PK concentration result available. Number analyzed signifies the number of participants with available data at the specific timepoint.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=17 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=32 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=29 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 1
|
10005.9 nanogram per milliliter (ng/ml)
Standard Deviation 4147.35
|
9411.5 nanogram per milliliter (ng/ml)
Standard Deviation 7762.98
|
11821.2 nanogram per milliliter (ng/ml)
Standard Deviation 5456.11
|
15339.4 nanogram per milliliter (ng/ml)
Standard Deviation 3514.51
|
6612.4 nanogram per milliliter (ng/ml)
Standard Deviation 2315.16
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 2
|
8697.9 nanogram per milliliter (ng/ml)
Standard Deviation 3540.53
|
7775.0 nanogram per milliliter (ng/ml)
Standard Deviation 2646.11
|
10521.4 nanogram per milliliter (ng/ml)
Standard Deviation 3448.39
|
13868.6 nanogram per milliliter (ng/ml)
Standard Deviation 4143.59
|
8465.5 nanogram per milliliter (ng/ml)
Standard Deviation 6553.50
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 3
|
10600.0 nanogram per milliliter (ng/ml)
Standard Deviation 3879.40
|
11472.5 nanogram per milliliter (ng/ml)
Standard Deviation 3684.63
|
13682.2 nanogram per milliliter (ng/ml)
Standard Deviation 3093.84
|
14324.4 nanogram per milliliter (ng/ml)
Standard Deviation 5532.63
|
6824.0 nanogram per milliliter (ng/ml)
Standard Deviation 2911.62
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 4
|
7787.8 nanogram per milliliter (ng/ml)
Standard Deviation 3334.11
|
9230.0 nanogram per milliliter (ng/ml)
Standard Deviation 1980.08
|
11703.3 nanogram per milliliter (ng/ml)
Standard Deviation 2284.15
|
12560.0 nanogram per milliliter (ng/ml)
Standard Deviation 4625.17
|
7122.9 nanogram per milliliter (ng/ml)
Standard Deviation 3084.39
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 5
|
9744.3 nanogram per milliliter (ng/ml)
Standard Deviation 1816.91
|
9675.0 nanogram per milliliter (ng/ml)
Standard Deviation 1308.15
|
13220.0 nanogram per milliliter (ng/ml)
Standard Deviation 2049.06
|
13487.1 nanogram per milliliter (ng/ml)
Standard Deviation 4458.46
|
7305.0 nanogram per milliliter (ng/ml)
Standard Deviation 3089.01
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 6
|
8050.0 nanogram per milliliter (ng/ml)
Standard Deviation 2418.64
|
10195.0 nanogram per milliliter (ng/ml)
Standard Deviation 3825.45
|
12983.8 nanogram per milliliter (ng/ml)
Standard Deviation 3182.10
|
13025.7 nanogram per milliliter (ng/ml)
Standard Deviation 5043.89
|
6904.3 nanogram per milliliter (ng/ml)
Standard Deviation 2516.11
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 7
|
7908.0 nanogram per milliliter (ng/ml)
Standard Deviation 3111.60
|
9940.0 nanogram per milliliter (ng/ml)
Standard Deviation NA
Standard deviation (SD) cannot be calculated for 1 participant.
|
12600.0 nanogram per milliliter (ng/ml)
Standard Deviation 1803.70
|
—
|
—
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Cycle 8
|
2253.0 nanogram per milliliter (ng/ml)
Standard Deviation 2214.31
|
—
|
12501.3 nanogram per milliliter (ng/ml)
Standard Deviation 2658.79
|
—
|
—
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Debio 1562: Month 38
|
—
|
—
|
—
|
—
|
15000.0 nanogram per milliliter (ng/ml)
Standard Deviation NA
Standard deviation (SD) cannot be calculated for 1 participant.
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 1
|
213287.4 nanogram per milliliter (ng/ml)
Standard Deviation 55735.54
|
207415.8 nanogram per milliliter (ng/ml)
Standard Deviation 67408.74
|
179430.7 nanogram per milliliter (ng/ml)
Standard Deviation 41213.48
|
170942.3 nanogram per milliliter (ng/ml)
Standard Deviation 28871.50
|
171006.4 nanogram per milliliter (ng/ml)
Standard Deviation 37226.83
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 2
|
251697.6 nanogram per milliliter (ng/ml)
Standard Deviation 41113.07
|
214761.9 nanogram per milliliter (ng/ml)
Standard Deviation 40919.84
|
191988.5 nanogram per milliliter (ng/ml)
Standard Deviation 65788.33
|
205481.9 nanogram per milliliter (ng/ml)
Standard Deviation 43738.73
|
210563.7 nanogram per milliliter (ng/ml)
Standard Deviation 43723.39
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 3
|
272302.8 nanogram per milliliter (ng/ml)
Standard Deviation 58497.66
|
213378.8 nanogram per milliliter (ng/ml)
Standard Deviation 36470.96
|
239380.8 nanogram per milliliter (ng/ml)
Standard Deviation 60127.34
|
218358.1 nanogram per milliliter (ng/ml)
Standard Deviation 49891.16
|
254760.9 nanogram per milliliter (ng/ml)
Standard Deviation 107449.36
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 4
|
283067.9 nanogram per milliliter (ng/ml)
Standard Deviation 57414.89
|
198313.3 nanogram per milliliter (ng/ml)
Standard Deviation 79455.19
|
262263.9 nanogram per milliliter (ng/ml)
Standard Deviation 67895.19
|
236146.8 nanogram per milliliter (ng/ml)
Standard Deviation 63699.49
|
267141.2 nanogram per milliliter (ng/ml)
Standard Deviation 65390.99
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 5
|
366032.9 nanogram per milliliter (ng/ml)
Standard Deviation 94593.53
|
156582.0 nanogram per milliliter (ng/ml)
Standard Deviation 82703.21
|
266406.1 nanogram per milliliter (ng/ml)
Standard Deviation 52480.70
|
282017.6 nanogram per milliliter (ng/ml)
Standard Deviation 66512.79
|
267163.1 nanogram per milliliter (ng/ml)
Standard Deviation 51180.64
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 6
|
354142.7 nanogram per milliliter (ng/ml)
Standard Deviation 90095.73
|
200913.0 nanogram per milliliter (ng/ml)
Standard Deviation 130086.43
|
240735.0 nanogram per milliliter (ng/ml)
Standard Deviation 114120.93
|
294989.5 nanogram per milliliter (ng/ml)
Standard Deviation 82301.31
|
296240.1 nanogram per milliliter (ng/ml)
Standard Deviation 68962.34
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 7
|
341761.4 nanogram per milliliter (ng/ml)
Standard Deviation 37261.58
|
179381.0 nanogram per milliliter (ng/ml)
Standard Deviation NA
Standard deviation (SD) cannot be calculated for 1 participant.
|
281045.9 nanogram per milliliter (ng/ml)
Standard Deviation 62528.32
|
114902.0 nanogram per milliliter (ng/ml)
Standard Deviation NA
Standard deviation (SD) cannot be calculated for 1 participant.
|
—
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Cycle 8
|
379038.7 nanogram per milliliter (ng/ml)
Standard Deviation 83552.42
|
—
|
251326.4 nanogram per milliliter (ng/ml)
Standard Deviation 85797.08
|
—
|
—
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Month 37
|
77330.7 nanogram per milliliter (ng/ml)
Standard Deviation 34343.07
|
59503.5 nanogram per milliliter (ng/ml)
Standard Deviation 9683.76
|
53960.9 nanogram per milliliter (ng/ml)
Standard Deviation 61954.05
|
86046.4 nanogram per milliliter (ng/ml)
Standard Deviation 53904.82
|
73469.1 nanogram per milliliter (ng/ml)
Standard Deviation 47009.66
|
|
Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab
Rituximab: Month 38
|
107690.6 nanogram per milliliter (ng/ml)
Standard Deviation 56044.52
|
82585.0 nanogram per milliliter (ng/ml)
Standard Deviation 31312.62
|
78777.3 nanogram per milliliter (ng/ml)
Standard Deviation 72013.43
|
69646.9 nanogram per milliliter (ng/ml)
Standard Deviation 49779.31
|
79561.6 nanogram per milliliter (ng/ml)
Standard Deviation 55656.86
|
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow upPopulation: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs firstPopulation: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).
PFS was defined as the duration between the first dose date of Debio 1562 and the date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is defined as the new or clear progression of preexisting non-measured lesions or regrowth of previously resolved lesions or a new node \>1.5 cm in any axis or an abnormal lesion with \>1.5 cm longest transverse diameter or increase by \>50% of lesion.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=15 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=11 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
1.4 months
Interval 1.2 to 11.1
|
1.8 months
Interval 1.3 to 4.0
|
20.7 months
Interval 10.5 to
Upper limit of 95% Confidence Interval (CI) was not estimable due to the low number of participants with events.
|
5.1 months
Interval 1.4 to
Upper limit of 95% Confidence Interval (CI) was not estimable due to the low number of participants with events.
|
4.6 months
Interval 1.4 to 13.4
|
SECONDARY outcome
Timeframe: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs firstPopulation: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded.
TTR was defined as the duration between the first dose date of Debio 1562 and the date of first objective response (PR or CR). CR was defined as disappearance of all target lesions, no new lesions formation. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤ 1.5 cm. PR was defined as ≥50% decrease in the sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=4 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=1 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=9 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=15 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=15 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Time to Response (TTR)
|
1.4 months
Interval 1.2 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
1.4 months
Lower and upper limits of 95% CI was not estimable due to the low number of participants with events.
|
1.4 months
Interval 1.4 to 2.1
|
1.5 months
Interval 1.4 to 1.8
|
1.5 months
Interval 1.4 to 3.3
|
SECONDARY outcome
Timeframe: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs firstPopulation: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded.
DOR was defined as duration between date of the first objective response (PR or CR) and date of PD or death due to any cause, whichever occurs first. CR: Disappearance of all target lesions, no new lesions formation, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤1.5 cm. PR: ≥50% decrease in sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation. PD: New or clear progression of preexisting non-measured lesions or regrowth of previously resolved lesions or a new node \>1.5 cm in any axis or an abnormal lesion with \>1.5 cm longest transverse diameter or increase by \>50% of lesion.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=4 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=1 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=9 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=15 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=15 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
NA months
Interval 9.7 to
Median and upper limit of 95% CI was not estimable due to the low number of participants with events.
|
2.6 months
Lower and upper limits of 95% CI was not estimable due to the low number of participants with events.
|
NA months
Interval 13.2 to
Median and upper limit of 95% CI was not estimable due to the low number of participants with events.
|
NA months
Interval 13.6 to
Median and upper limit of 95% CI was not estimable due to the low number of participants with events.
|
16.5 months
Interval 3.4 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Up to death or end of study (approximately 57 months) or one year from the last participant's first dosePopulation: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).
OS was defined as the duration between the first dose date of Debio 1562 and the date of death due to any cause.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=15 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=11 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
30.0 months
Interval 13.3 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
8.4 months
Interval 2.7 to 17.0
|
34.3 months
Interval 24.3 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
NA months
Interval 11.4 to
Median and upper limit of 95% CI was not estimable due to the low number of participants with events.
|
17.3 months
Interval 9.5 to
Upper limit of 95% CI was not estimable due to the low number of participants with events.
|
SECONDARY outcome
Timeframe: Part 1: Pre-dose on Day 1 of Cycle(C)1 to 8; Part 2/3: Pre-dose on Day 1 of C1 to 6 and on Day 1 of C7 for participants who received treatment beyond C6 (each C=21 days); Parts 1, 2/3: Month 37 (EOT) and Month 38 (30-Day FU visit) (Cycle=21 days)Population: ADA population included all participants who received at least one dose of Debio 1562 or rituximab and had at least one ADA post exposure result available. Overall number of participants analyzed signifies number of participants with non-missing ADA value at baseline and at least one non-missing post-treatment value.
The potential immunogenicity against Debio 1562 was assessed in an ADA population.
Outcome measures
| Measure |
Part 1: Safety Run-in
n=14 Participants
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=6 Participants
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=10 Participants
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=30 Participants
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=25 Participants
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA) for Debio 1562
No Change From Baseline
|
13 Participants
|
6 Participants
|
10 Participants
|
25 Participants
|
20 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Debio 1562
Decrease in ADA Titer From Baseline
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Anti-drug Antibodies (ADA) for Debio 1562
Increase in ADA Titer From Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Part 1: Safety Run-in
Serious events: 5 serious events
Other events: 15 other events
Deaths: 11 deaths
Part 1: Cohort 1
Serious events: 3 serious events
Other events: 8 other events
Deaths: 6 deaths
Part 1: Cohort 2
Serious events: 5 serious events
Other events: 12 other events
Deaths: 5 deaths
Part 2/3: Cohort A
Serious events: 15 serious events
Other events: 32 other events
Deaths: 16 deaths
Part 2/3: Cohort B
Serious events: 9 serious events
Other events: 29 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Part 1: Safety Run-in
n=17 participants at risk
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 participants at risk
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 participants at risk
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 participants at risk
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 participants at risk
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Circulatory collpase
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
General physical health deterioration
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
9.1%
3/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Pyrexia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Post procedural fever
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Oral pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue mass
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
COVID-19
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Device related infection
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Gangrene
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Sinusitis aspergillus
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
Other adverse events
| Measure |
Part 1: Safety Run-in
n=17 participants at risk
Participants with a diagnosis of R/R DLBCL, and with NHL including FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 1
n=8 participants at risk
Participants with R/R DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 1: Cohort 2
n=12 participants at risk
Participants with R/R, FL, MZL/MALT, MCL or other NHL with the Sponsor's approval received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of 21-day cycles until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort A
n=33 participants at risk
Participants with relapsed DLBCL received Debio 1562 0.7 mg/kg, IV infusion followed by rituximab 375 mg/m\^2 IV infusion, once on Day 1 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
Part 2/3: Cohort B
n=30 participants at risk
Participants with relapsed DLBCL received Debio 1562 0.4 mg/kg IV infusion followed by rituximab 375 mg/m\^2 IV infusion on Day 1, then Debio 1562 0.2 mg/kg IV infusion on Days 8 and 15 of a 21-day cycle for at least 6 cycles and/or until the study discontinuation criteria were met (until they develop disease progression, death, unacceptable toxicity, withdraw consent, start new anti-lymphoma treatment or the Sponsor terminates the study).
|
|---|---|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Tachycardia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Rhinitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Hypertension
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
9.1%
3/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Flushing
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Hot flush
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Hypotension
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Lymphostasis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Deep vein thrombosis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant muscle neoplasm
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Fatigue
|
47.1%
8/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
21.2%
7/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Pyrexia
|
23.5%
4/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
2/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
18.2%
6/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
13.3%
4/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Asthenia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
5/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Oedema peripheral
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Chills
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Hyperthermia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Pain
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Chest pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Facial pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
General disorders
Swelling
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Psychiatric disorders
Insomnia
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Psychiatric disorders
Confusional state
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Reproductive system and breast disorders
Breast pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Neutrophil count decreased
|
35.3%
6/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Lymphocyte count decreased
|
29.4%
5/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
White blood cell count decreased
|
29.4%
5/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
10.0%
3/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Platelet count decreased
|
23.5%
4/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Alanine aminotransferase increased
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
2/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Blood alkaline phosphatase increased
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Weight decreased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Blood bilirubin increased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Body temperature increased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Haemoglobin decreased
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Cardiac murmur
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Troponin increased
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
Weight increased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Investigations
White blood cell count increased
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Acute myocardial infarction
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
63.6%
21/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
56.7%
17/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
24.2%
8/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
20.0%
6/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
15.2%
5/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
23.3%
7/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
2/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
21.2%
7/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
5/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.1%
4/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
20.0%
6/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.3%
6/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
2/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
50.0%
6/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
9.1%
3/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
41.7%
5/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
13.3%
4/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Dizziness
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Dysgeusia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Cognitive disorder
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Diabetic neuropathy
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Hypoaesthesia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Taste disorder
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Nervous system disorders
Visual field defect
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Eye disorders
Eye disorder
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Eye disorders
Eye pruritus
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
2/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
41.7%
5/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
15.2%
5/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
33.3%
4/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
13.3%
4/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
4/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
10.0%
3/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
20.0%
6/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Constipation
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
10.0%
3/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Renal and urinary disorders
Pollakiuria
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Renal and urinary disorders
Urinary incontinence
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Lividity
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
9.1%
3/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
25.0%
3/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Amyotrophy
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Iliolumbar syndrome
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.4%
5/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
10.0%
3/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.1%
2/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
11.8%
2/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Urinary tract infection
|
17.6%
3/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.5%
1/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
9.1%
3/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Bronchitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
12.1%
4/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Pneumonia
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
10.0%
3/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.3%
1/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Sinusitis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
16.7%
2/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
6.7%
2/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Oral candidiasis
|
5.9%
1/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
3.0%
1/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Furuncle
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Sinusitis aspergillus
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Skin infection
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
|
Infections and infestations
Influenza
|
0.00%
0/17 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/8 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
8.3%
1/12 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/33 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
0.00%
0/30 • All-cause mortality: Up to end of study (approximately 57 months); Adverse events: Up to 30 days after EOT (Up to 38 months)
Safety Population included all participants from the screened population who received at least 1 dose of Debio 1562.
|
Additional Information
Vice President Clinical Research & Development
Debiopharm International S.A.
Phone: 4121 321 01 11
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication or scientific communication related to this study can only take place once an agreement between the Sponsor and the Investigator has been reached.
- Publication restrictions are in place
Restriction type: OTHER