Trial Outcomes & Findings for Plitidepsin Versus Control in Immunocompromised Adult Participants With Symptomatic COVID-19 Requiring Hospital Care (NEREIDA) (NCT NCT05705167)
NCT ID: NCT05705167
Last Updated: 2024-12-02
Results Overview
In the event of the participant initiating another non-protocol therapy, 1-month all-cause mortality rate was evaluated regardless of initiation of new non-protocol therapy.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
Day 1 to Day 30 (±2)
Results posted on
2024-12-02
Participant Flow
A total of 37 participants were enrolled at 15 investigative sites between April 2023 and April 2024. Randomised participants who received at least 1 dose of study treatment and completed follow-up for survival until Day 30 (±2) were included in the Full Analysis Set (FAS) population.
Participant milestones
| Measure |
Group 1: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute intravenous (IV) infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 2: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
11
|
11
|
1
|
1
|
8
|
|
Overall Study
COMPLETED
|
2
|
1
|
7
|
3
|
0
|
0
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
4
|
8
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute intravenous (IV) infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 2: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Randomised but not Treated
|
0
|
2
|
0
|
7
|
0
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
3
|
0
|
1
|
1
|
1
|
|
Overall Study
Discontinued Prior to FAS Eligibility
|
0
|
0
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Ethnicity was not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=25 Participants
|
|
Age, Customized
≥ 65 years - < 75 years
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
6 Participants
n=10 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=25 Participants
|
|
Age, Customized
≥ 75 years
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=10 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
5 Participants
n=10 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
10 Participants
n=10 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=25 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=25 Participants
|
|
Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Ethnicity was not collected from any participant.
|
PRIMARY outcome
Timeframe: Day 1 to Day 30 (±2)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
In the event of the participant initiating another non-protocol therapy, 1-month all-cause mortality rate was evaluated regardless of initiation of new non-protocol therapy.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
One-month All-cause Mortality Rate
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
SECONDARY outcome
Timeframe: Day 1 to Day 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
Time to confirmed negativisation in SARS-CoV antigen test or RT-PCR Ct\>30 was calculated as time from randomisation to the corresponding event using Kaplan-Meier (KM) estimates. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Time to Confirmed Negativisation in SARS-CoV-2 Antigen Test or Real Time Polymerase Chain Reaction (RT-PCR) Cycle Threshold (Ct) > 30
|
14.0 days
Interval 4.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
61.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
2.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
14.0 days
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
13.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
10.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
14.0 days
Interval 3.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: Day 1 to Day 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
Time to sustained end of COVID-related hospital care from the time of randomisation was calculated as time from randomisation to the corresponding event using KM estimates. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Time to Sustained End of COVID-related Hospital Care
|
37.0 days
Interval 13.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
20.5 days
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
4.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
4.5 days
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
24.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
2.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
7.0 days
Interval 3.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: Day 1 to Day 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
Time to sustained improvement and resolution of all targeted COVID-19 signs/symptoms was calculated as time from randomisation to the corresponding event using KM estimates. Corresponding events were defined as the event occurring on the first of 4 consecutive days when all symptoms scored as National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0; category of moderate-severe intensity, or requiring medical intervention, or limiting instrumental activity of daily living are scored as mild or absent AND all symptoms scored mild or 0 (absent) at study entry are scored as 0. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Time to Sustained Improvement and Resolution of Selected COVID-19 Signs/Symptoms
|
14.0 days
Interval 4.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
NA days
Interval 5.0 to
Median and upper confidence interval were not calculable due to fewer than 50% events.
|
NA days
Median and confidence intervals were not calculable due to insufficient event data.
|
NA days
Interval 3.0 to
Median and upper confidence interval were not calculable due to fewer than 50% events.
|
17.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
2.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
37.0 days
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population. Number of participants analysed represents participants with available data at each individual timepoint.
Distribution of participants according to their clinical status by the 11-category WHO CPS: * Uninfected; no viral ribonucleic acid (RNA) detected * Asymptomatic; viral RNA detected * Symptomatic; independent * Symptomatic; assistance needed * Hospitalised; no oxygen therapy * Hospitalised; oxygen by mask or nasal prongs * Hospitalised; oxygen by non-invasive ventilation (NIV) or high flow * Intubation and mechanical ventilation * Mechanical ventilation or vasopressors * Mechanical ventilation and vasopressors, dialysis, or extracorporeal membrane oxygenation (ECMO) OR * Death.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Asymptomatic; viral RNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Symptomatic; independent
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Symptomatic; assistance needed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Hospitalised; no oxygen therapy
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Hospitalised; oxygen by NIV or high flow
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Hospitalised; oxygen by NIV or high flow
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Mechanical ventilation and vasopressors, dialysis, or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Asymptomatic; viral RNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
2 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Symptomatic; independent
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Symptomatic; assistance needed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Hospitalised; oxygen by NIV or high flow
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Mechanical ventilation or vasopressors
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Uninfected; no viral RNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Asymptomatic; viral RNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Symptomatic; independent
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Hospitalised; oxygen by mask or nasal prongs
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Symptomatic; assistance needed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Hospitalised; no oxygen therapy
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
—
|
5 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Hospitalised; oxygen by mask or nasal prongs
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Hospitalised; oxygen by NIV or high flow
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Mechanical ventilation or vasopressors
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Mechanical ventilation and vasopressors, dialysis, or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 4 · Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Uninfected; no viral RNA detected
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Symptomatic; independent
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Symptomatic; assistance needed
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Hospitalised; no oxygen therapy
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Hospitalised; oxygen by mask or nasal prongs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Mechanical ventilation or vasopressors
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Uninfected; no viral RNA detected
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
2 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Hospitalised; no oxygen therapy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Hospitalised; oxygen by mask or nasal prongs
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Mechanical ventilation or vasopressors
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Mechanical ventilation and vasopressors, dialysis, or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 30 · Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Uninfected; no viral RNA detected
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
—
|
4 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Asymptomatic; viral RNA detected
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Symptomatic; independent
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Symptomatic; assistance needed
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Hospitalised; no oxygen therapy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Hospitalised; oxygen by mask or nasal prongs
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Hospitalised; oxygen by NIV or high flow
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Intubation and mechanical ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Mechanical ventilation or vasopressors
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Mechanical ventilation and vasopressors, dialysis, or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 8 · Dead
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Uninfected; no viral RNA detected
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 15 · Asymptomatic; viral RNA detected
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants in Each Category of the World Health Organization (WHO) Clinical Progression Scale (CPS)
Day 60 · Mechanical ventilation and vasopressors, dialysis, or ECMO
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 4 (±1), 8 (±1), 15 (±1), 30 (±2), and 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
The maximum number of participants requiring oxygen therapy on any day during each visit window is reported.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Requiring Oxygen Therapy
Day 30
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Requiring Oxygen Therapy
Day 60
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Requiring Oxygen Therapy
Day 4
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Requiring Oxygen Therapy
Day 8
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Requiring Oxygen Therapy
Day 15
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 60 (±3)Population: FAS Population: All randomised participants who received at least 1 dose of study treatment (plitidepsin or control) and completed follow-up for survival until Day 30 (±2). Participants who died before the end of the follow-up period were also included in the FAS population.
Time to sustained discontinuation is calculated as time from randomisation to the corresponding event using KM estimates. Corresponding events were defined as discontinuation of oxygen supplementation for at least 7 days. Participants with no available data for any time to event efficacy endpoint were censored at time 0, end of study (Day 60 ±3), or date of early study termination. Also, participants who had not achieved the time to event endpoint were censored at the last valid assessment.
Outcome measures
| Measure |
Group 2: Control
n=3 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=10 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=7 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Time to Sustained Discontinuation of Oxygen Supplementation
|
NA days
Interval 34.0 to
Median and upper confidence interval were not calculable due to fewer than 50% events.
|
13.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
NA days
Median and confidence intervals were not calculable due to insufficient event data occurring.
|
63.0 days
Interval 1.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
NA days
Median and confidence intervals were not calculable due to insufficient event data occurring below the median.
|
14.0 days
Confidence intervals were not calculable due to insufficient event data occurring near the median.
|
14.0 days
Interval 2.0 to
Upper confidence interval was not calculable due to insufficient event data occurring above the median.
|
SECONDARY outcome
Timeframe: Day 1 to Day 60 (±3)Population: As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
Frequency of the following events (all-cause and treatment-related) are included: * TEAEs * TEAEs ≥ grade 3 according to the NCI CTCAE v5.0 * TEAEs of special interest * Serious TEAEs * Serious adverse reactions (SARs) * AEs leading to treatment discontinuation * Deaths (related to COVID-19/all) Clinically relevant/significant changes from Baseline in laboratory parameters and vital signs were reported as AEs.
Outcome measures
| Measure |
Group 2: Control
n=4 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 1: Plitidepsin 2.5 mg
n=2 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=11 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=8 Participants
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any serious TEAE
|
4 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related serious TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any TEAE leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any TEAE
|
4 Participants
|
1 Participants
|
1 Participants
|
10 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any TEAE ≥ grade 3
|
4 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related TEAE ≥ grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any TEAE of special interest
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related TEAE of special interest
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related TEAE leading to treatment discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Any treatment-related TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1: Plitidepsin 2.5 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 1: Control
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2: Plitidepsin 2.5 mg
Serious events: 5 serious events
Other events: 10 other events
Deaths: 3 deaths
Group 2: Control
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3: Plitidepsin 2.5 mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Group 3: Control
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Group 4: Plitidepsin 2.5 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1: Plitidepsin 2.5 mg
n=2 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=11 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 2: Control
n=4 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=8 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Generalised oedema
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
50.0%
2/4 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Septic shock
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Stenotrophomonas infection
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Tuberculosis
|
50.0%
1/2 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Coma
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
18.2%
2/11 • Number of events 3 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
Other adverse events
| Measure |
Group 1: Plitidepsin 2.5 mg
n=2 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 1: Control
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 1.
Group 1 - Participants who received immune-suppression due to haematopoietic or organ transplantation.
|
Group 2: Plitidepsin 2.5 mg
n=11 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 2: Control
n=4 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 2.
Group 2 - Participants who received B-cell depleting therapies.
|
Group 3: Plitidepsin 2.5 mg
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 3: Control
n=1 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) ± other regulatory-approved antiviral (if clinically indicated) were administered to participants in Group 3.
Group 3 - Participants who received other immune-suppressive therapies.
|
Group 4: Plitidepsin 2.5 mg
n=8 participants at risk
Best standard care (as per applicable local, institutional, national, supranational COVID-19 treatment guidelines) and plitidepsin (administered as a 60-minute IV infusion, every 24 hours for 3 consecutive days, at a dose of 2.5 mg) were administered to participants in Group 4.
Group 4 - Other situations with immune deficiencies.
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Slow speech
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Malaise
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
2/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
18.2%
2/11 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
37.5%
3/8 • Number of events 3 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
1/2 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
18.2%
2/11 • Number of events 5 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Gastrointestinal sounds abnormal
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
27.3%
3/11 • Number of events 3 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Chills
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Pain
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 3 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
45.5%
5/11 • Number of events 7 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
50.0%
2/4 • Number of events 4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Immune system disorders
Haemophagocytic lymphohistiocytosis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
50.0%
2/4 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Blood urea increased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Cardiac murmur
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Urine output decreased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
50.0%
1/2 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
2/8 • Number of events 4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
27.3%
3/11 • Number of events 3 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
75.0%
3/4 • Number of events 7 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
100.0%
1/1 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
50.0%
4/8 • Number of events 4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
25.0%
1/4 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
18.2%
2/11 • Number of events 2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
9.1%
1/11 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/8 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
|
Vascular disorders
Vein disorder
|
0.00%
0/2 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/11 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/4 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
0.00%
0/1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
12.5%
1/8 • Number of events 1 • Up to Day 60 (±3)
As Treated Population: All participants who received any exposure to study treatment (plitidepsin or control). As Treated population was analysed according to the treatment they actually received.
|
Additional Information
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Pharma Mar, S.A.
Phone: +34 918466000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place