Trial Outcomes & Findings for Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors (NCT NCT05126433)
NCT ID: NCT05126433
Last Updated: 2025-02-28
Results Overview
The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline to disease progression or death, up to 36 weeks.
Results posted on
2025-02-28
Participant Flow
A total of 47 participants who met all eligibility criteria were enrolled and received treatment were included
Participant milestones
| Measure |
Urothelial Cancer (UC) Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
20
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
20
|
Reasons for withdrawal
| Measure |
Urothelial Cancer (UC) Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
4
|
|
Overall Study
Death
|
9
|
3
|
5
|
|
Overall Study
Study Terminated by sponsor
|
0
|
1
|
2
|
|
Overall Study
Progressive Disease
|
1
|
4
|
3
|
|
Overall Study
Sponsor decision- no further OS follow up required
|
2
|
4
|
6
|
Baseline Characteristics
Lurbinectedin Monotherapy in Participants With Advanced or Metastatic Solid Tumors
Baseline characteristics by cohort
| Measure |
Urothelial Cancer (UC) Cohort
n=15 Participants
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=20 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to disease progression or death, up to 36 weeks.Population: Assessed in participants with available data in the Efficacy Analysis Set. To be included in the Efficacy Analysis Set, participant must have a measurable disease at baseline and one of the following: a) at least 1 post-baseline tumor assessment, b) clinical progression, or c) death. One participant in the HRD Cohort was not included in the Efficacy Analysis Set due to not meeting the criteria.
The ORR is defined as the proportion of participants whose best overall response (BOR) is investigator-assessed confirmed complete response (CR) or partial response (PR) using the RECIST v1.1 criteria. BOR is defined as the best response recorded between the date of first dose and the date of objectively documented progression per RECIST v1.1, or the date of subsequent anticancer therapy, death due to any cause, loss to follow-up, or study discontinuation, whichever occurs first.
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
n=15 Participants
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=19 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Investigator-Assessed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
|
0 Participants
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death, up to 36 weeksPFS is defined as the time from the first dosing date to the date of first documented disease progression or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
n=15 Participants
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=19 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Investigator-Assessed Progression Free Survival (PFS) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
|
1.46 months
Interval 0.89 to 3.32
|
2.07 months
Interval 1.18 to 2.89
|
1.38 months
Interval 1.35 to 2.79
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death, up to 36 weeksPopulation: Only study treatment responders were included in the data set. There were no responders in the UC cohort, 2 responders in the PD-NEC cohort and 1 in the HRD cohort.
TTR is defined as the time from the first dosing date to the date of the first confirmed response (complete response \[CR\] or partial response \[PR\]), as assessed by the investigators.
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=2 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=1 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Investigator-Assessed Time-To-Response (TTR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
|
—
|
2.76 months
Interval 2.7 to 2.8
|
1.31 months
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death, up to 36 weeksPopulation: Only study treatment responders were included in the data set. There were no responders in the UC cohort, 2 responders in the PD-NEC cohort and 1 in the HRD cohort.
DOR is defined as the time from the first confirmed response (complete response \[CR\] or partial response \[PR\]) to the date of the first documented tumor progression as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=2 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=1 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Investigator-Assessed Duration of Response (DOR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
|
—
|
5.67 months
Interval 2.8 to 8.6
|
2.79 months
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death, up to 36 weeks.Population: Assessed in participants with available data in the Efficacy Analysis Set. To be included in the Efficacy Analysis Set, participant must have a measurable disease at baseline and one of the following: a) at least 1 post-baseline tumor assessment, b) clinical progression, or c) death. One participant in the HRD Cohort was not included in the Efficacy Analysis Set due to not meeting the criteria.
DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed complete response (CR), or partial response (PR), or stable disease (SD) using the RECIST v1.1 criteria.
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
n=15 Participants
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=19 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Investigator-assessed Disease Control Rate (DCR) as Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1
|
4 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Baseline and every 3 months, up to 16 monthsOS is defined as the time from the first dosing date to the date of death from any cause. A participant who has not died will be censored at the last known alive date
Outcome measures
| Measure |
Urothelial Cancer (UC) Cohort
n=15 Participants
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 Participants
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=19 Participants
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Overall Survival (OS) in Participants Treated With Lurbinectedin
|
4.99 months
Interval 0.92 to 14.52
|
NA months
Interval 2.66 to
Median and upper CI was not estimable due to insufficient number of events
|
NA months
Interval 2.89 to
Median and upper CI was not estimable due to insufficient number of events
|
Adverse Events
Urothelial Cancer (UC) Cohort
Serious events: 9 serious events
Other events: 15 other events
Deaths: 9 deaths
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
Serious events: 3 serious events
Other events: 12 other events
Deaths: 3 deaths
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
Serious events: 8 serious events
Other events: 19 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Urothelial Cancer (UC) Cohort
n=15 participants at risk
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 participants at risk
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=20 participants at risk
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Fatigue
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Sepsis
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Product Issues
Device occlusion
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
Other adverse events
| Measure |
Urothelial Cancer (UC) Cohort
n=15 participants at risk
Participants with advanced (metastatic and/or unresectable) urothelial carcinoma who have progressed on platinum-containing regimen (prior therapies may include but are not limited to immune checkpoint inhibitor, enformumab vendotin, or sacituzumab govitecan) will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort
n=12 participants at risk
Participants with advanced (metastatic and/or unresectable) poorly differentiated neuroendocrine carcinomas who received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
Homologous Recombination Deficient-Positive Malignancies Agnostic (HRD) Cohort
n=20 participants at risk
Participants with advanced (metastatic and/or unresectable) endometrial, biliary tract, urothelial, breast (TNBC or HR+HER2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation and received at least 1 prior line of therapy will receive Lurbinectedin 3.2 mg/m\^2 intravenous (IV) on Day 1 of every 3 weeks (Q3W) cycle until confirmed disease progression, withdrawal of participant consent, participant lost to follow-up, unacceptable toxicity, or the study or individual cohort may be terminated by the sponsor for lack of efficacy signal or any other reason.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.0%
9/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Cardiac disorders
Angina pectoris
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Abdominal pain
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
20.0%
4/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
50.0%
6/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
20.0%
4/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
33.3%
4/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Eructation
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
50.0%
6/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
45.0%
9/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Gastrointestinal disorders
Vomiting
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
35.0%
7/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Fatigue
|
40.0%
6/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
50.0%
6/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
40.0%
8/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Localised oedema
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Oedema peripheral
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Peripheral swelling
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Abdominal infection
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
COVID-19
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Candida infection
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Infections and infestations
Urinary tract infection
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
3/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
33.3%
4/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
25.0%
5/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
3/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
25.0%
3/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
20.0%
4/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
5/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
33.3%
4/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Blood bilirubin increased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Blood creatinine increased
|
20.0%
3/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
3/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Gamma-glutamyltransferase increased
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Lymphocyte count decreased
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Neutrophil count decreased
|
40.0%
6/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Neutrophil count increased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Platelet count decreased
|
46.7%
7/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
30.0%
6/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
Procalcitonin increased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
White blood cell count decreased
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Investigations
White blood cell count increased
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
25.0%
5/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
26.7%
4/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Brain fog
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Cognitive disorder
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
16.7%
2/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
15.0%
3/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Dyskinesia
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
20.0%
4/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Nervous system disorders
Syncope
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Psychiatric disorders
Confusional state
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Psychiatric disorders
Hallucination
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
5.0%
1/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
8.3%
1/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
0.00%
0/12 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
10.0%
2/20 • Adverse events were collected from the start of dosing of study drug up until 30 days after last study dose, up to approximately 10 months.
Assessed in 47 participants who received at least 1 dose of study treatment and were therefore included the Safety Analysis Set.
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals Inc.
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place