Trial Outcomes & Findings for A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma (NCT NCT05121103)
NCT ID: NCT05121103
Last Updated: 2025-06-22
Results Overview
An adverse event was any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily had a causal relationship with this treatment. A serious adverse event was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-subject hospitalization or prolongation of hospitalization, resulted in persistent or significant disability or incapacity, or resulted in a congenital abnormality or birth defect, was an important medical event. A TEAE was an AE that started or worsened in severity on or after the date of the first dose of the study treatment through 30 days after the end of treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
13 participants
Primary outcome timeframe
From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days
Results posted on
2025-06-22
Participant Flow
This first-in-human, Phase I/Ib, open-label, multi-center study was conducted in participants with relapsed/refractory (R/R) multiple myeloma (MM) and R/R diffuse large B cell lymphoma (DLBCL) at 15 investigational sites for Part 1 (dose escalation). The study was planned to be conducted in 2 parts: Part 1 and Part 2 (dose expansion). The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
The study was planned to have a screening period (28 days), treatment period (Part 1 and Part 2) and safety follow-up period (30 days). Due to early study termination, only results of the Part 1 are presented. A total of 13 participants were enrolled in Part 1 of the study. EZM0414 is also referred to as IPN60210.
Participant milestones
| Measure |
Part 1: EZM0414 100 mg
Participants with translocation (t)(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 milligrams (mg) tablet orally once daily (QD) in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
6
|
Reasons for withdrawal
| Measure |
Part 1: EZM0414 100 mg
Participants with translocation (t)(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 milligrams (mg) tablet orally once daily (QD) in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
1
|
6
|
|
Overall Study
Physician Decision
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Diffuse Large B Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Part 1: EZM0414 100 mg
n=4 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
n=3 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
n=6 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 7.42 • n=93 Participants
|
70.3 years
STANDARD_DEVIATION 6.66 • n=4 Participants
|
68.0 years
STANDARD_DEVIATION 13.11 • n=27 Participants
|
66.5 years
STANDARD_DEVIATION 10.29 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 daysPopulation: The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
An adverse event was any untoward medical occurrence in a participant or clinical investigation participant administered a medicinal product and which does not necessarily had a causal relationship with this treatment. A serious adverse event was any untoward medical occurrence that at any dose, resulted in death, was life-threatening, required in-subject hospitalization or prolongation of hospitalization, resulted in persistent or significant disability or incapacity, or resulted in a congenital abnormality or birth defect, was an important medical event. A TEAE was an AE that started or worsened in severity on or after the date of the first dose of the study treatment through 30 days after the end of treatment.
Outcome measures
| Measure |
Part 1: EZM0414 100 mg
n=4 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
n=3 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
n=6 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TEAEs
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
TESAEs
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose of study treatment (Cycle 1 Day 1) up to end of the Cycle 1 (Cycle 1 Day 28), maximum of 28 daysPopulation: The DLT evaluable population included dose escalation dose level participants in the Safety population who received at least 80% of planned study treatment during Cycle 1.
According to National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0, DLT was defined as any of following AE that occurred in Part 1 during first cycle of study treatment: grade (G)4 neutropenia lasting \>5 days; G3 febrile neutropenia; G3 thrombocytopenia with clinically significant bleeding; G4 thrombocytopenia; G4 anemia unexplained by underlying disease; any other non-hematological toxicity ≥3 except: alopecia, G3 nausea/vomiting or diarrhea for \<3 days with supportive care, G3 fatigue for \<1 week, G3 or higher isolated electrolyte abnormalities for up to 3 days, not clinically complicated, and resolved spontaneously, or responded to conventional medical interventions; G3 or higher amylase/lipase elevation without symptoms of pancreatitis; G3 tumor lysis syndrome for up to 3 days, not clinically complicated, and resolved spontaneously, or responded to conventional medical interventions; and any participant meeting Hy's law criteria.
Outcome measures
| Measure |
Part 1: EZM0414 100 mg
n=4 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
n=3 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
n=6 Participants
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 monthsPopulation: The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
ORR was planned to be assessed in Part 2. ORR was defined as percentage of responders as assessed by Investigator per International Myeloma Working Group (IMWG) 2016 guidelines for MM (complete response \[CR\], stringent CR \[sCR\], partial response \[PR\], very good PR \[VGPR\]) or Lugano 2014 guidelines for DLBCL (CR+PR). Per IMWG response criteria, CR: negative immunofixation on serum and urine; disappearance of soft tissue plasmacytomas; \<5% plasma cells in bone marrow(BM); sCR: CR + normal free light chain (FLC) ratio; absence of BM clonal cells by immunohistochemistry; VGPR: serum and urine M-protein (MP) detected by immunofixation but not on electrophoresis or ≥90% reduction in serum MP + urine MP\<100 mg/24 hours (h) or ≥90% decrease in sum of maximal perpendicular diameter (SPD) compared to baseline in soft tissue plasmacytoma; PR: ≥50% reduction of serum MP and reduction in 24 h urinary M-protein by ≥90% or to \<200 mg/24 h; ≥50% reduction in size (SPD) of soft tissue plasmacytomas.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 monthsPopulation: The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
PFS was planned to be assessed in Part 2. PFS was defined as the time from start of treatment until the first documented progressive disease (PD), as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL or death due to any cause, whichever occurred first. Per IMWG response criteria, PD was defined as any 1 or more of the following criteria: a) increase of ≥25% from lowest confirmed value in either serum MP, serum MP increase ≥1 gram/deciliter (g/dL) if the lowest M-component was ≥5 g/dL or urine M-component, b) appearance of new lesion(s), ≥50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 centimeter (cm) in short axis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 monthsPopulation: The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
DCR was planned to be assessed in Part 2.DCR was defined as percentage of participants with confirmed CR,sCR,PR,VGPR,minimal response(MR) or stable disease(SD) per IMWG 2016 guidelines for MM/CR,PR, or SD per Lugano 2014 guidelines for DLBCL.Per IMWG response criteria,CR:negative immunofixation on serum and urine;disappearance of soft tissue plasmacytomas;\<5% plasma cells in BM; sCR:CR+normal FLC ratio;absence of BM clonal cells by immunohistochemistry; VGPR:serum and urine MP detected by immunofixation but not electrophoresis or ≥90% reduction in serum MP+urine MP\<100 mg/24h or ≥90% decrease in SPD in soft tissue plasmacytoma; PR:≥50% reduction of serum MP and reduction in 24h urinary M-protein by ≥90% or to \<200mg/24h;≥50% reduction in size(SPD) of soft tissue plasmacytomas. MR:≥25% but ≤49% reduction in serum MP and reduction in 24h urine MP by 50-89%, which exceed 200 mg/24h; ≥50% reduction in size(SPD) of soft tissue plasmacytomas.SD:Not meeting criteria for CR,VGPR,PR,MR, or PD.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Tumour assessments were planned to be performed at Screening (within 28 days before start of study treatment) or Cycle 1 Day 1 (pre-dose) up to end of the study, approximately 23 monthsPopulation: The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
DOR was planned to be assessed in Part 2. DOR was defined as the time from initial CR or PR to documented progression or death, whichever came first, as assessed by Investigator per IMWG 2016 guidelines for MM or Lugano 2014 guidelines for DLBCL. Per IMWG response criteria, CR: negative immunofixation on serum and urine; disappearance of any soft tissue plasmacytomas; \<5% plasma cells in BM. PR: ≥50% reduction of serum MP and reduction in 24 h urinary M-protein by ≥90% or to \<200 mg/24 h; ≥50% reduction in the size (SPD) of soft tissue plasmacytomas. PD: any 1 or more of the following criteria: a) increase of ≥25% from lowest confirmed value in either serum MP, serum MP increase ≥1 g/dL if the lowest M-component was ≥5 g/dL or urine M-component, b) appearance of new lesion(s), ≥50% increase from nadir in SPD of \>1 lesion, or ≥50% increase in the longest diameter of a previous lesion \>1 cm in short axis.
Outcome measures
Outcome data not reported
Adverse Events
Part 1: EZM0414 100 mg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: EZM0414 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1: EZM0414 300 mg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 1: EZM0414 100 mg
n=4 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
n=3 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
n=6 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Infections and infestations
Urosepsis
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
Other adverse events
| Measure |
Part 1: EZM0414 100 mg
n=4 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 100 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 200 mg
n=3 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 200 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
Part 1: EZM0414 300 mg
n=6 participants at risk
Participants with t(4;14) R/R MM or non-t(4;14) R/R MM or R/R DLBCL received EZM0414 300 mg tablet orally QD in continuous 28-day cycles (except on Days 2 and 3 of Cycle 1) until consent withdrawal, unacceptable toxicity, disease progression or need for treatment prohibited on this study.
|
|---|---|---|---|
|
Investigations
Platelet count decreased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
66.7%
2/3 • Number of events 4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
Amylase increased
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
Protein total increased
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Fatigue
|
50.0%
2/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Face oedema
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Dry mouth
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Vascular disorders
Hypotension
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
50.0%
3/6 • Number of events 4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Cardiac disorders
Sinus tachycardia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Psychiatric disorders
Anxiety
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Psychiatric disorders
Confusional state
|
25.0%
1/4 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Number of events 2 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/6 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
0.00%
0/3 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment (Day 57), up to approximately 87 days. All-cause mortality (death) was assessed from first dose of study treatment (Day 1) up to early termination of the study, approximately 23 months.
The safety population included all participants who received at least 1 dose of the study treatment in Part 1. The study was terminated prior to completing Part 1 of the study. Part 2 was not started.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place