Trial Outcomes & Findings for A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy (NCT NCT04150029)
NCT ID: NCT04150029
Last Updated: 2026-01-13
Results Overview
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibily related to MBG453 as a single contributor or in combination with other component(s) of study treatment that occurs during the DLT observation period and meets any of the criteria as per protolcol.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
From Cycle 1 Day 8 to end of Cycle 2; Cycle =28 Days
Results posted on
2026-01-13
Participant Flow
This study was conducted in 28 centers across 10 countries with a total of 90 participants enrolled.
Informed consent was obtained from each participant in writing before screening before any study specific procedure was performed.
Participant milestones
| Measure |
MBG453 400 mg + Venetoclax +Azacitidine
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
MBG453 800 mg + Venetoclax +Azacitidine
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
85
|
|
Overall Study
Did not enter post-treatment follow-up
|
4
|
60
|
|
Overall Study
Entered post-treatment follow-up
|
1
|
25
|
|
Overall Study
Entered survival follow-up
|
5
|
85
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
85
|
Reasons for withdrawal
| Measure |
MBG453 400 mg + Venetoclax +Azacitidine
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
MBG453 800 mg + Venetoclax +Azacitidine
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
|---|---|---|
|
Overall Study
Disease Relapse
|
0
|
18
|
|
Overall Study
Progressive Disease
|
2
|
16
|
|
Overall Study
Adverse Event
|
1
|
11
|
|
Overall Study
Physician Decision
|
0
|
10
|
|
Overall Study
Study Terminated by Sponsor
|
1
|
10
|
|
Overall Study
Death
|
0
|
8
|
|
Overall Study
Participant Decision
|
0
|
7
|
|
Overall Study
Hemopoietic Stem Cell Transplant (HSCT)
|
1
|
5
|
Baseline Characteristics
A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy
Baseline characteristics by cohort
| Measure |
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
76.8 Years
STANDARD_DEVIATION 4.97 • n=9 Participants
|
76.1 Years
STANDARD_DEVIATION 6.33 • n=6 Participants
|
76.1 Years
STANDARD_DEVIATION 6.24 • n=9 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
39 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=9 Participants
|
47 Participants
n=6 Participants
|
51 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White
|
5 Participants
n=9 Participants
|
69 Participants
n=6 Participants
|
74 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=9 Participants
|
13 Participants
n=6 Participants
|
13 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
|
Body surface area (BSA)
|
1.88 m^2
STANDARD_DEVIATION 0.105 • n=9 Participants
|
1.84 m^2
STANDARD_DEVIATION 0.252 • n=6 Participants
|
1.84 m^2
STANDARD_DEVIATION 0.246 • n=9 Participants
|
|
ECOG performance status
ECOG performance status: 0
|
1 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
ECOG performance status
ECOG performance status: 1
|
2 Participants
n=9 Participants
|
43 Participants
n=6 Participants
|
45 Participants
n=9 Participants
|
|
ECOG performance status
ECOG performance status: 2
|
2 Participants
n=9 Participants
|
24 Participants
n=6 Participants
|
26 Participants
n=9 Participants
|
|
ECOG performance status
ECOG performance status: 3
|
0 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: From Cycle 1 Day 8 to end of Cycle 2; Cycle =28 DaysPopulation: The Dose-Determining Set (DDS) included all participants from the FAS enrolled in the safety run-in part who met the minimum exposure criterion and had sufficient safety evaluations or experienced a dose limiting toxicity (DLT) starting from Cycle 1 Day 8 to the end of Cycle 2. FAS comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value considered by the Investigator to be at least possibily related to MBG453 as a single contributor or in combination with other component(s) of study treatment that occurs during the DLT observation period and meets any of the criteria as per protolcol.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=11 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=4 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only)
Cardiac disorders - All grades
|
1 Participants
|
0 Participants
|
|
Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only)
Participants with at least 1 event - All grades
|
1 Participants
|
0 Participants
|
|
Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only)
Participants with at least 1 event - Grade >= 3
|
0 Participants
|
0 Participants
|
|
Incidence of Dose Limiting Toxicities (DLT)(Safety run-in Patients Only)
Cardiac disorders - Grades >= 3
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: approx. 31 monthsPopulation: All participants in the Full Analysis Set (FAS) and assigned to MBG453 at the 800 mg Q4W dose level. FAS comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
CR rate is defined as the percentage of participants achieving a complete remission (CR) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Percentage of Participants Achieving Complete Remission (CR) (CR Rate)
|
—
|
47.06 Percentage of participants
Interval 36.1 to 58.2
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Measurable Residual Disease (MRD) - Negativity Rate: Full Study Population
|
42.4 Percentage of participants
Interval 31.7 to 53.6
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: All participants in FAS with the best overall response of CR or CRi and who are evaluable for MRD. The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). A participant is considered as evaluable for MRD if he/she had at least one post-baseline sample with MRD negative or MRD positive.
MRD negativity rate was defined as the percentage of participants with MRD negativity, which was defined as an MRD negative sample (frequency of LAIP below 0.1%, as determined by Multi-parameter Flow Cytometry-Measurable residual disease (MFC-MRD) at Central Lab) in participant with remission (i.e., CR or CRi) as per investigator assessment (based on IWG Cheson et al 2003, ELN 2017 Dohner et al 2017). MRD-negative response was required to be observed at or after morphological remission, and prior to relapse or disease progression.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=49 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=3 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Measurable Residual Disease (MRD) - Negativity Rate in Participants With Best Overall Response (BOR) of CR/CRi and Evaluable MRD
|
73.5 Percentage of participants
Interval 58.9 to 85.1
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR.
The duration of CR is defined as the time from first achievement of CR to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=40 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=4 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Duration of Complete Remission (CR)
|
10.28 Months
Interval 6.28 to
NA: upper limit of confidence interval was not achieved due to small sample size and short duration of follow-up.
|
NA Months
Interval 7.56 to
NA: median and upper limit of confidence interval was not achieved due to small sample size and short duration of follow-up.
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
CR/CRi rate is defined as the percentage pf participants with best overall response of either complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) as per investigator assessment (based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017)).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Incomplete Hematologic Blood Count Recovery (CRi) (CR/CRi Rate)
|
69.4 Percentage of participants
Interval 58.5 to 79.0
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR or CRi.
The duration of CR/CRi is defined as the time from first achievement of CR or CRi to the first documented relapse or progressive disease or death due to any cause, whichever occurs first. The response assessment is as per investigator assessment based on IWG (Cheson et al 2003) and ELN 2017 (Dohner et al 2017).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=59 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=4 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
The Duration of Complete Remission (CR)/Complete Remission With Incomplete Blood Count Recovery (CRi)
|
8.54 Months
Interval 5.98 to 13.67
|
NA Months
Interval 7.56 to
NA: Median and upper limit of CI were not achieved due to small sample size and short duration of follow-up.
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
CR/CRh rate is defined as the percentage of participants with best overall response of either complete remission (CR) or complete remission with partial hematologic recovery (CRh) as per derivation based on ELN 2022 (Döhner et al 2022).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Percentage of Participants Achieving a Complete Remission (CR) or Complete Remission With Partial Hematologic Blood Count Recovery (CRh) (CR/CRh Rate)
|
50.6 Percentage of participants
Interval 39.5 to 61.6
|
80.0 Percentage of participants
Interval 28.4 to 99.5
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax). This was based on participants with best overall response of CR or CRh.
The duration of CR/CRh is defined as the time from date of first documented CR or CRh to the date of first documented relapse or death due to any cause, whichever occurs first. The response assessment is as per derivation based on ELN 2022 (Döhner et al 2022).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=43 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=4 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Duration of CR/CRh
|
12.45 Months
Interval 6.83 to 14.78
|
NA Months
Interval 7.56 to
NA: Median and upper limit of confidence interval were not achieved due to small sample size and short duration of follow-up.
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
EFS is the time from start of treatment until death due to any cause, relapse from complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or treatment failure, whichever occurs first. Treatment failure was defined as lack of reaching CR until Cycle 8 Day 1 or earlier permanent discontinuation from study without reaching CR, the time to treatment failure was then set to Day 1.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Event Free Survival (EFS)
|
0.03 Months
Interval 0.03 to 6.14
|
8.28 Months
Interval 0.03 to
NA: upper limit of confidence interval was not achieved due to small sample size and short duration of follow-up.
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
OS is the time from start of treatment to death due to any cause. If a participant was not known to have died, then OS was censored at the latest date the participant was known to be alive (on or before the cut-off date).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Overall Survival (OS)
|
13.27 Months
Interval 9.49 to 18.14
|
11.17 Months
Interval 5.32 to
NA: Upper limit of confidence interval was not achieved due to small sample size and short duration of follow-up.
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8 (end of infusion) and Cycle 3 Day 8 (end of infusion), cycle = 28 daysPopulation: The sabatolimab pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration for the two populations.
Cmax is the maximal concentration of MBG453.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=81 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Peak Serum Concentration (Cmax) of MBG453
Cycle 1 Day 8: 2 hr (post-dose)
|
204 ug/ml
Geometric Coefficient of Variation 35.3
|
84.0 ug/ml
Geometric Coefficient of Variation 20.0
|
|
Peak Serum Concentration (Cmax) of MBG453
Cycle 3 Day 8: 2 hr (post-dose)
|
261 ug/ml
Geometric Coefficient of Variation 40.9
|
129 ug/ml
Geometric Coefficient of Variation 4.9
|
SECONDARY outcome
Timeframe: Day 8 of Cycle 1,2,3,6,9,12,18, 24 and through treatment completion, an average of 24 monthsPopulation: The sabatolimab pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable sabatolimab PK concentration for the two populations.
Cmin is the minimum concentration of MBG453 (i.e., prior to the next dosing).
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=81 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 1 Day 8: 0 hr (pre-dose)
|
0 ug/ml
Geometric Coefficient of Variation 0
|
0 ug/ml
Geometric Coefficient of Variation 0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 2 Day 8: 0 hr (pre-dose)
|
18.8 ug/ml
Geometric Coefficient of Variation 68.9
|
8.79 ug/ml
Geometric Coefficient of Variation 70.8
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 3 Day 8: 0 hr (pre-dose)
|
30.7 ug/ml
Geometric Coefficient of Variation 80.9
|
12.4 ug/ml
Geometric Coefficient of Variation 16.0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 6 Day 8: 0 hr (pre-dose)
|
45.1 ug/ml
Geometric Coefficient of Variation 79.5
|
17.6 ug/ml
Geometric Coefficient of Variation 0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 9 Day 8: 0 hr (pre-dose)
|
72.9 ug/ml
Geometric Coefficient of Variation 60.0
|
6.55 ug/ml
Geometric Coefficient of Variation 0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 12 Day 8: 0 hr (pre-dose)
|
78.1 ug/ml
Geometric Coefficient of Variation 62.7
|
17.4 ug/ml
Geometric Coefficient of Variation 0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 18 Day 8: 0 hr (pre-dose)
|
70.4 ug/ml
Geometric Coefficient of Variation 96.5
|
9.76 ug/ml
Geometric Coefficient of Variation 0
|
|
Trough Serum Concentration (Cmin) MBG453
Cycle 24 Day 8: 0 hr (pre-dose)
|
61.4 ug/ml
Geometric Coefficient of Variation 84.1
|
30.6 ug/ml
Geometric Coefficient of Variation 0
|
SECONDARY outcome
Timeframe: 0 hr (Pre-dose) of Day 8 of Cycle 1, 3 and 6 ; Cycle =28 daysPopulation: The venetoclax pharmacokinetic analysis set included all participants from the Safety Set who provided at least one evaluable venetoclax PK concentration for the two populations.
Trough concentration of venetoclax on treatment
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=62 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=3 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Trough Plasma Concentration (Cmin) Venetoclax
Cycle 1 day 8: 0 hr pre-dose)
|
972 ng/ml
Geometric Coefficient of Variation 97.5
|
378 ng/ml
Geometric Coefficient of Variation 86.4
|
|
Trough Plasma Concentration (Cmin) Venetoclax
Cycle 3 day 8: 0 hr pre-dose)
|
1010 ng/ml
Geometric Coefficient of Variation 154.8
|
730 ng/ml
Geometric Coefficient of Variation 8.6
|
|
Trough Plasma Concentration (Cmin) Venetoclax
Cycle 6 day 8: 0 hr pre-dose)
|
959 ng/ml
Geometric Coefficient of Variation 64.1
|
—
|
SECONDARY outcome
Timeframe: at baseline, up to 150 days after last treatment, approx. 24 monthsPopulation: Immunogenicity Incidence Set includes all participants in the Immunogenicity prevalence set with a non-missing baseline ADA sample and at least one non-missing post-baseline ADA sample. The Immunogenicity prevalence set includes all participants in the Safety Set with a non-missing baseline ADA sample or at least one non-missing post-baseline ADA sample.
Immunogenicity (IG) to MBG453 prior to MBG453 exposure. ADA prevalence (i.e., ADA-positive samples) is the number of ADA-positive samples among the number of participants with a non-missing sample.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=74 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Positive Participants On-treatment
ADA prevalence at baseline (BL)
|
4 Participants
|
0 Participants
|
|
Anti-drug Antibody (ADA) Prevalence at Baseline and ADA Positive Participants On-treatment
ADA-positive participants on-treatment
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: approx. 31 monthsPopulation: The Full Analysis Set (FAS) comprised all participants who received at least one dose of any component of the study treatment (i.e. at least one dose of sabatolimab or at least one dose of azacitidine or at least one dose of venetoclax).
Percentage of participants having received no RBC/Platelets transfusions during at least 8 consecutive weeks.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
Rate of Participants Who Achieved Transfusion Independence From Baseline and While on Treatment
RBC: transfusion independence at post-BL
|
57.6 Percentage of participants
Interval 46.4 to 68.3
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
|
Rate of Participants Who Achieved Transfusion Independence From Baseline and While on Treatment
Platelet transfusion independence at post-baseline
|
65.9 Percentage of participants
Interval 54.8 to 75.8
|
60.0 Percentage of participants
Interval 14.7 to 94.7
|
POST_HOC outcome
Timeframe: from randomization until end of trial, approx. 31 months.Population: Clinical database population: All participants: participants who died during treatment and post-treatment.
Deaths were collected from treatment start until the end of the trial, approx. 31 months including post-treatment and survival follow-up period.
Outcome measures
| Measure |
MBG453 800 mg + Venetoclax +Azacitidine
n=85 Participants
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
MBG453 400 mg + Venetoclax +Azacitidine
n=5 Participants
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
|---|---|---|
|
All Collected Deaths
On-treatment deaths
|
11 Participants
|
1 Participants
|
|
All Collected Deaths
Post-treatment deaths
|
45 Participants
|
2 Participants
|
|
All Collected Deaths
All deaths
|
56 Participants
|
3 Participants
|
Adverse Events
MBG453 400 mg + Venetoclax +Azacitidine
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
MBG453 800 mg + Venetoclax +Azacitidine
Serious events: 67 serious events
Other events: 85 other events
Deaths: 56 deaths
Serious adverse events
| Measure |
MBG453 400 mg + Venetoclax +Azacitidine
n=5 participants at risk
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
MBG453 800 mg + Venetoclax +Azacitidine
n=85 participants at risk
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
35.3%
30/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Immune-mediated pericarditis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
General physical health deterioration
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Malaise
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
15.3%
13/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
COVID-19
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Device related infection
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Enterocolitis infectious
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Infection
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Splenic infection fungal
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chloroma
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Embolism
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
Other adverse events
| Measure |
MBG453 400 mg + Venetoclax +Azacitidine
n=5 participants at risk
Participants received 400 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) of the study.
|
MBG453 800 mg + Venetoclax +Azacitidine
n=85 participants at risk
Participants received 800 mg MBG453 in combination with Venetoclax (VEN) and Azacitidine (AZA). This arm was used in Part 1 (Safety Run-in phase) and Part 2 (Expansion Part) of the study.
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
23.5%
20/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
31.8%
27/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
16.5%
14/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
45.9%
39/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
8.2%
7/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
18.8%
16/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Constipation
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
56.5%
48/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
43.5%
37/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Haemorrhoids
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
37.6%
32/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
15.3%
13/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
24.7%
21/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Asthenia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
12.9%
11/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Axillary pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Catheter site irritation
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Chest discomfort
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Chest pain
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Fatigue
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
27.1%
23/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Influenza like illness
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Injection site erythema
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Injection site reaction
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
8.2%
7/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Injection site swelling
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Mucosal inflammation
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Oedema
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Oedema peripheral
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
29.4%
25/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
36.5%
31/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
COVID-19
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
18.8%
16/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Influenza
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Oral candidiasis
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Pneumonia
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
15.3%
13/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
12.9%
11/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
11.8%
10/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
8.2%
7/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Blood alkaline phosphatase increased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
15.3%
13/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Neutrophil count decreased
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
25.9%
22/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Platelet count decreased
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
34.1%
29/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Troponin T increased
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
16.5%
14/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Investigations
White blood cell count decreased
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
18.8%
16/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
20.0%
17/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
11.8%
10/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
12.9%
11/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
34.1%
29/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
22.4%
19/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
21.2%
18/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
16.5%
14/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
12.9%
11/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
14.1%
12/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Dizziness
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
18.8%
16/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
20.0%
17/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
3.5%
3/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Syncope
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
1.2%
1/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Psychiatric disorders
Confusional state
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Reproductive system and breast disorders
Oedema genital
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
20.0%
17/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
14.1%
12/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
8.2%
7/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
9.4%
8/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
7.1%
6/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
60.0%
3/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
23.5%
20/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
4.7%
4/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
5.9%
5/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
10.6%
9/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Hypotension
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
23.5%
20/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
2.4%
2/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
|
Vascular disorders
Scalp haematoma
|
20.0%
1/5 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
0.00%
0/85 • Adverse Events (AEs) were collected from the date of first administration of study treatment to 30 days after the date of the last administration of study treatment, up to maximum duration of 42.3 months (MBG453 400mg cohort) and 37.6 months (MBG453 800mg cohort). Deaths were collected from randomization until end of trial, approx. 31 months.
Any sign or symptom that occurred during the conduct of the trial and the safety follow-up. Deaths in the post-treatment survival follow-up period are not considered adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER