Trial Outcomes & Findings for Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003) (NCT NCT03645395)
NCT ID: NCT03645395
Last Updated: 2022-08-16
Results Overview
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. A DLT is any TEAE that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 1 year
Results posted on
2022-08-16
Participant Flow
This two-part \[Part 1: Dose Escalation and Part 2: maximum tolerated dose (MTD) Expansion Cohort\] study evaluated the safety and tolerability of MT-3724 in combination with Lenalidomide (LEN) in participants with relapsed or refractory CD20 positive B-cell Lymphoma.
Total 9 participants were enrolled in the study. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Participant milestones
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
Participants were administered MT-3724 10 micrograms per kilograms/dose intravenously (mcg/kg/dose IV) on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 (Up to 6 Months)
STARTED
|
3
|
3
|
3
|
0
|
|
Part 1 (Up to 6 Months)
COMPLETED
|
1
|
0
|
0
|
0
|
|
Part 1 (Up to 6 Months)
NOT COMPLETED
|
2
|
3
|
3
|
0
|
|
Part 2 (Up to 6 Months)
STARTED
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 6 Months)
COMPLETED
|
0
|
0
|
0
|
0
|
|
Part 2 (Up to 6 Months)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
Participants were administered MT-3724 10 micrograms per kilograms/dose intravenously (mcg/kg/dose IV) on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 (Up to 6 Months)
Adverse Event
|
1
|
0
|
0
|
0
|
|
Part 1 (Up to 6 Months)
Disease Progression
|
0
|
1
|
0
|
0
|
|
Part 1 (Up to 6 Months)
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Part 1 (Up to 6 Months)
Sponsor's decision to close the trial
|
1
|
2
|
2
|
0
|
Baseline Characteristics
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Lenalidomide for the Treatment of Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (MT-3724_NHL_003)
Baseline characteristics by cohort
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 8.33 • n=99 Participants
|
61.3 Years
STANDARD_DEVIATION 8.33 • n=107 Participants
|
71.0 Years
STANDARD_DEVIATION 12.77 • n=206 Participants
|
—
|
64.9 Years
STANDARD_DEVIATION 9.83 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
—
|
6 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
5 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Safety Population included participants who received at least one dose of any study drug (either MT-3724, or lenalidomide). Part 2 was not initiated due to Sponsor's decision to terminate the trial.
An adverse event is any untoward medical occurrence or clinical investigation in a participant administered a pharmaceutical product(s) and which does not necessarily have to have a causal relationship with this experimental treatment(s). SAE is any untoward medical occurrence, at any dose; is fatal or life-threatening, is life-threatening, results in permanently disabling; results in unplanned in-patient hospitalization or prolongation of existing hospitalization; results in a congenital abnormality or birth defect; important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention. A DLT is any TEAE that occurred after the start of infusion in cycle 1 of Part 1 and the TEAE is at least possibly related to the study drug, as determined by the sponsor after consultation with the investigator(s).
Outcome measures
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity
DLT
|
0 participants
|
2 participants
|
0 participants
|
—
|
|
Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity
TEAEs
|
3 participants
|
3 participants
|
3 participants
|
—
|
|
Part 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) and Dose-limiting Toxicity
SAEs
|
1 participants
|
1 participants
|
1 participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Safety Population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Laboratory parameters included hematology, blood chemistry, and urinalysis. Any abnormal laboratory test results which were considered clinically significant by the investigator were recorded on the case report form. Number of participants with any clinically significant abnormalities in laboratory parameters have been presented.
Outcome measures
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 and 2: Number of Participants With Abnormal Laboratory Parameters
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1,3 and 12 of treatment cycle (Each cycle is of 28 days); Up to 1 yearPopulation: PK population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PK assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Blood samples were collected for Pharmacokinetic (PK) analysis of MT-3724. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
Outcome measures
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 and 2: Plasma Concentrations of MT-3724
|
NA Micrograms per milliliter
Standard Deviation NA
Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
|
NA Micrograms per milliliter
Standard Deviation NA
Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
|
NA Micrograms per milliliter
Standard Deviation NA
Mean and Standard Deviation could not be calculated due to high proportion of non-quantifiable values (\>30 percent \[%\] of values were imputed)
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Pharmacodynamic (PD) Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline PD assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Blood samples were collected for analysis of B-cell count. Data could not be calculated due to small sample size and inconsistent sampling as a result of early termination.
Outcome measures
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 and 2: Change From Baseline in B-cell Count
|
NA Giga cells per liter
Standard Deviation NA
Mean and Standard Deviation could not be calculated as 100% of the data was below the limit of quantification at all time points.
|
NA Giga cells per liter
Standard Deviation NA
Mean and Standard Deviation could not be calculated as 100% of the data was below the limit of quantification at all time points.
|
NA Giga cells per liter
Standard Deviation NA
Mean and Standard Deviation could not be calculated as 100% of the data was below the limit of quantification at all time points.
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Blood samples were collected for analysis of ADA titer. Data was not collected due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Immunogenicity Population included all participants who received at least one dose of MT-3724 and have at least one post-baseline immunogenicity assessment. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
Blood samples were planed to be collected for analysis of neutralizing antibody (NAb) titers. Data was not collected due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial. The rows presenting data for PR and CR are mutually exclusive.
ORR was defined as CR or Partial Response (PR). CR: a score 1 (no uptake above background), 2 (uptake \<=mediastinum), or 3 (\<mediastinum but \<=liver) with or without a residual mass on PET 5-PS, for lymph nodes and extralymphatic sites with no new lesions and no evidence of FDG-avid disease in bone marrow. PR: a score 4 (uptake moderately greater than \[\>\] liver) or 5 (uptake markedly \>liver and/or new lesions) with reduced uptake compared with baseline and residual mass(es) of any size on PET 5-PS for lymph nodes and extralymphatic sites with no new lesions and reduced residual uptake in bone marrow compared with baseline. Higher score indicates worse outcomes.
Outcome measures
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 Participants
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Part 1 and 2: Number of Participants With Objective Response Rate (ORR)
PR
|
2 participants
|
0 participants
|
1 participants
|
—
|
|
Part 1 and 2: Number of Participants With Objective Response Rate (ORR)
CR
|
1 participants
|
2 participants
|
1 participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
DOR is defined as the time from the first documented complete or partial response to the actual date of disease progression or death before progression. Data was not collected due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
PFS is defined as the time from first dose date until the first occurrence of documented disease progression or death from any cause in the absence of progressive disease. Data was not collected due to early termination of the trial.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Safety population. Part 2 was not initiated due to Sponsor's decision to terminate the trial.
OS is defined as the time from date of start of treatment to date of death due to any cause. Data was not collected due to early termination of the trial.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: MT-3724 10 mcg/Kg-LEN
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: MT-3724 25 mcg/Kg-LEN
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: MT-3724 20 mcg/Kg-LEN
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 2: MT-3724 50mcg/Kg-LEN
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Cardiac disorders
Congestive heart failure
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Bacteraemia
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • Number of events 1 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
Other adverse events
| Measure |
Part 1: MT-3724 10 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 10 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 25 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 25 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 1: MT-3724 20 mcg/Kg-LEN
n=3 participants at risk
Participants were administered MT-3724 20 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants self-administered 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
Part 2: MT-3724 50mcg/Kg-LEN
Participants were to be administered MT-3724 50 mcg/kg/dose IV on Days 1,3,5,8, 10 and 12 on Cycle 1 and 2 and Cycle 3 onwards Days 1,8,15 and 22. Participants were to self-administer 20 mg LEN on the first 21 consecutive days (D1-D21) of each 28-day cycle.
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
100.0%
3/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
100.0%
3/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Renal and urinary disorders
Proteinuria
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
General disorders
Chest discomfort
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Renal and urinary disorders
Glycosuria
|
66.7%
2/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Weight increased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Cardiac disorders
Left atrial enlargement
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
General disorders
Non-cardiac chest pain
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Transaminase increased
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
|
Investigations
Weight decreased
|
33.3%
1/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
0.00%
0/3 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
—
0/0 • All-cause mortality, non-serious TEAEs and SAEs were collected up to 1 year
Safety Population. Only data for Part 1 has been presented as study was terminated per the sponser's decision and Part 2 was not initiated.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER