Trial Outcomes & Findings for Aplidin - Dexamethasone in Relapsed/Refractory Myeloma (NCT NCT01102426)
NCT ID: NCT01102426
Last Updated: 2020-11-10
Results Overview
To compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
255 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Results posted on
2020-11-10
Participant Flow
A total of 255 patients were enrolled. 171 Group A (Plitidepsin in combination with DXM) and 84 Group B (DXM alone). Enrolled patients between 29Jun10 and 19May15 (Last randomization). The first dose of the first patient was given on 19May15 and the last dose of the last patient was given on 07Aug17.
Participant milestones
| Measure |
Plitidepsin+Dexamethasone
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
171
|
84
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
165
|
81
|
Reasons for withdrawal
| Measure |
Plitidepsin+Dexamethasone
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
4
|
1
|
|
Overall Study
Adverse Events (treatment-related)
|
15
|
8
|
|
Overall Study
Physician Decision
|
9
|
6
|
|
Overall Study
Progressive Disease
|
85
|
44
|
|
Overall Study
Adverse Events (unrelated to
|
9
|
1
|
|
Overall Study
Patient Refusal
|
24
|
12
|
|
Overall Study
Death (due to adverse events
|
0
|
1
|
|
Overall Study
Death (non-related to the study
|
19
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=171 Participants
|
0 Participants
n=84 Participants
|
0 Participants
n=255 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=171 Participants
|
36 Participants
n=84 Participants
|
124 Participants
n=255 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=171 Participants
|
48 Participants
n=84 Participants
|
131 Participants
n=255 Participants
|
|
Age, Continuous
|
64 years
n=171 Participants
|
65 years
n=84 Participants
|
65 years
n=255 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=171 Participants
|
49 Participants
n=84 Participants
|
123 Participants
n=255 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=171 Participants
|
35 Participants
n=84 Participants
|
132 Participants
n=255 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
6 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
7 Participants
n=255 Participants
|
|
Region of Enrollment
Czechia
|
23 Participants
n=171 Participants
|
10 Participants
n=84 Participants
|
33 Participants
n=255 Participants
|
|
Region of Enrollment
United Kingdom
|
12 Participants
n=171 Participants
|
6 Participants
n=84 Participants
|
18 Participants
n=255 Participants
|
|
Region of Enrollment
Portugal
|
2 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
3 Participants
n=255 Participants
|
|
Region of Enrollment
Spain
|
13 Participants
n=171 Participants
|
7 Participants
n=84 Participants
|
20 Participants
n=255 Participants
|
|
Region of Enrollment
Greece
|
12 Participants
n=171 Participants
|
7 Participants
n=84 Participants
|
19 Participants
n=255 Participants
|
|
Region of Enrollment
New Zealand
|
7 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
8 Participants
n=255 Participants
|
|
Region of Enrollment
Austria
|
21 Participants
n=171 Participants
|
7 Participants
n=84 Participants
|
28 Participants
n=255 Participants
|
|
Region of Enrollment
South Korea
|
8 Participants
n=171 Participants
|
4 Participants
n=84 Participants
|
12 Participants
n=255 Participants
|
|
Region of Enrollment
Netherlands
|
5 Participants
n=171 Participants
|
4 Participants
n=84 Participants
|
9 Participants
n=255 Participants
|
|
ECOG PS
PS 0
|
68 Participants
n=171 Participants
|
31 Participants
n=84 Participants
|
99 Participants
n=255 Participants
|
|
ECOG PS
PS 1
|
74 Participants
n=171 Participants
|
42 Participants
n=84 Participants
|
116 Participants
n=255 Participants
|
|
ECOG PS
PS 2
|
28 Participants
n=171 Participants
|
11 Participants
n=84 Participants
|
39 Participants
n=255 Participants
|
|
ECOG PS
PS 3
|
1 Participants
n=171 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=255 Participants
|
|
MM type at diagnosis
Non Secretory
|
6 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
7 Participants
n=255 Participants
|
|
MM type at diagnosis
Secretory IgA
|
35 Participants
n=171 Participants
|
21 Participants
n=84 Participants
|
56 Participants
n=255 Participants
|
|
MM type at diagnosis
Secretory IgD
|
1 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
2 Participants
n=255 Participants
|
|
MM type at diagnosis
Secretory IgG
|
101 Participants
n=171 Participants
|
51 Participants
n=84 Participants
|
152 Participants
n=255 Participants
|
|
MM type at diagnosis
Secretory IgM
|
1 Participants
n=171 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=255 Participants
|
|
MM type at diagnosis
Secretory Light chain disease
|
27 Participants
n=171 Participants
|
10 Participants
n=84 Participants
|
37 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage A
|
0 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
1 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IA
|
21 Participants
n=171 Participants
|
9 Participants
n=84 Participants
|
30 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IB
|
0 Participants
n=171 Participants
|
2 Participants
n=84 Participants
|
2 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage II
|
3 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
4 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IIA
|
44 Participants
n=171 Participants
|
20 Participants
n=84 Participants
|
64 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IIB
|
1 Participants
n=171 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage III
|
2 Participants
n=171 Participants
|
1 Participants
n=84 Participants
|
3 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IIIA
|
85 Participants
n=171 Participants
|
43 Participants
n=84 Participants
|
128 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Stage IIIB
|
14 Participants
n=171 Participants
|
7 Participants
n=84 Participants
|
21 Participants
n=255 Participants
|
|
Durie-Salmon stage at diagnosis
Not Durie-Salmon stage at diagnosis
|
1 Participants
n=171 Participants
|
0 Participants
n=84 Participants
|
1 Participants
n=255 Participants
|
|
International Staging System at diagnosis
Stage I
|
72 Participants
n=171 Participants
|
33 Participants
n=84 Participants
|
105 Participants
n=255 Participants
|
|
International Staging System at diagnosis
Stage II
|
41 Participants
n=171 Participants
|
18 Participants
n=84 Participants
|
59 Participants
n=255 Participants
|
|
International Staging System at diagnosis
Stage III
|
23 Participants
n=171 Participants
|
15 Participants
n=84 Participants
|
38 Participants
n=255 Participants
|
|
International Staging System at diagnosis
Not stage at diagnosis
|
35 Participants
n=171 Participants
|
18 Participants
n=84 Participants
|
53 Participants
n=255 Participants
|
|
Cytogenetic risk group at diagnosis
Standard risk
|
34 Participants
n=171 Participants
|
21 Participants
n=84 Participants
|
55 Participants
n=255 Participants
|
|
Cytogenetic risk group at diagnosis
High risk
|
38 Participants
n=171 Participants
|
16 Participants
n=84 Participants
|
54 Participants
n=255 Participants
|
|
Cytogenetic risk group at diagnosis
NA/ND/UK
|
99 Participants
n=171 Participants
|
47 Participants
n=84 Participants
|
146 Participants
n=255 Participants
|
|
Prior radiotherapy
Yes
|
68 Participants
n=171 Participants
|
35 Participants
n=84 Participants
|
103 Participants
n=255 Participants
|
|
Prior radiotherapy
No
|
103 Participants
n=171 Participants
|
49 Participants
n=84 Participants
|
152 Participants
n=255 Participants
|
|
Hb
|
10.4 g/dL
n=171 Participants
|
10.1 g/dL
n=84 Participants
|
10.3 g/dL
n=255 Participants
|
|
Platelets
|
140 platelets*10^9/L
n=171 Participants
|
154 platelets*10^9/L
n=84 Participants
|
144 platelets*10^9/L
n=255 Participants
|
|
CrCL
|
72.9 mL/min
n=171 Participants
|
69.4 mL/min
n=84 Participants
|
71.9 mL/min
n=255 Participants
|
|
Time from first diagnosis to randomization
|
71.8 months
n=171 Participants
|
70 months
n=84 Participants
|
71.3 months
n=255 Participants
|
|
Time from last PD/relapse to first study dose
|
6.1 weeks
n=171 Participants
|
6.4 weeks
n=84 Participants
|
6.2 weeks
n=255 Participants
|
|
Beta-2 microglobulin
|
4.1 mg/L
n=171 Participants
|
4.2 mg/L
n=84 Participants
|
4.1 mg/L
n=255 Participants
|
|
Number of lines of prior systemic therapy
|
4 lines
n=171 Participants
|
4 lines
n=84 Participants
|
4 lines
n=255 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 yearsTo compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Progression Free Survival (PFS) as Per Intention-to-treat (ITT)
|
2.6 months
Interval 1.9 to 3.0
|
1.7 months
Interval 1.1 to 2.0
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 monthsTo compare the efficacy of plitidepsin in combination with dexamethasone vs. dexamethasone alone as measured by progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (MM). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Progression Free Survival (PFS) as Per Intention-to-treat (ITT) at 6 Months
|
20.0 percentage of participants
Interval 13.1 to 26.9
|
10.0 percentage of participants
Interval 2.0 to 18.0
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 yearsPopulation: All Randomized Patients
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Progression-free Survival (Investigator Assessment)
|
2.9 months
Interval 2.1 to 3.7
|
1.1 months
Interval 1.0 to 1.9
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 monthsThe secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Progression-free Survival (Investigator Assessment) at 6 Months
|
26.4 percentage of participants
Interval 19.1 to 33.7
|
8.1 percentage of participants
Interval 1.9 to 14.3
|
SECONDARY outcome
Timeframe: From randomization to the death due to any cause,assessed up to 5 yearsPopulation: All Randomized Patients
Overall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Survival
|
11.6 months
Interval 9.2 to 16.1
|
8.9 months
Interval 6.0 to 15.4
|
SECONDARY outcome
Timeframe: From randomization to the death due to any cause,assessed up to 12 monthsOverall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Overall Survival at 12 Months
|
48.3 percentage of participants
Interval 40.4 to 56.2
|
42.1 percentage of participants
Interval 31.3 to 52.9
|
SECONDARY outcome
Timeframe: From randomization to the death due to any cause,assessed up to 24 monthsOverall Survival (OS) is defined as the time from the date of randomization to the date of death or last contact
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Overall Survival at 24 Months
|
30.8 percentage of participants
Interval 23.3 to 38.3
|
21.0 percentage of participants
Interval 12.0 to 30.1
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsPopulation: Patients with documentation of response
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=39 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=3 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Duration of Response (Independent Review Committee)
|
3.7 months
Interval 2.7 to 10.5
|
1.8 months
Interval 1.8 to 5.5
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 monthsPopulation: Patients with documentation of response
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=39 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=3 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Duration of Response (Independent Review Committee) at 6 Months
|
41.2 percentage of participants
Interval 24.6 to 57.7
|
0.0 percentage of participants
Interval 0.0 to
not reached
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsPopulation: Patients with documentation of response
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=51 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=1 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Duration of Response (Investigator Assessment)
|
5.1 months
Interval 3.2 to 6.2
|
0.9 months
not reached
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 6 monthsPopulation: Patients with documentation of response
DR was calculated from the date of first documentation of response to the date of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=51 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=1 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Percentage of Participants With Duration of Response (Investigator Assessment) at 6 Months
|
38.2 percentage of participants
Interval 23.7 to 52.8
|
0.0 percentage of participants
Interval 0.0 to
not reached
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsVery good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL; NE, not evaluable
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Best Overall Response (Independent Review Committee)
VGR
|
2 Participants
|
0 Participants
|
|
Best Overall Response (Independent Review Committee)
PR
|
15 Participants
|
1 Participants
|
|
Best Overall Response (Independent Review Committee)
MR
|
22 Participants
|
2 Participants
|
|
Best Overall Response (Independent Review Committee)
SD
|
43 Participants
|
21 Participants
|
|
Best Overall Response (Independent Review Committee)
PD
|
41 Participants
|
35 Participants
|
|
Best Overall Response (Independent Review Committee)
NE
|
48 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsOverall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Response Rate (Independent Review Committee)
|
22.8 percentage of participants
Interval 16.8 to 29.8
|
3.6 percentage of participants
Interval 0.7 to 10.1
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsIncludes sCR, CR, VGPR and PR (excludes MR). Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Response Rate (Independent Review Committee) Excluding MR
|
9.9 percentage of participants
Interval 5.9 to 15.4
|
1.2 percentage of participants
Interval 0.03 to 6.5
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsVery good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions Stable disease (SD) No sCR, CR, VGPR, PR, MR or PD Progressive disease (PD) 25% increase from the lowest value: serum M-protein, urine M-protein, BM plasma cell. Increase in size, new bone lesions, soft tissue plasmacytomas or serum calcium \>11.5 mg/dL; NE, not evaluable
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Best Overall Response (Investigator Assessment)
VGPR
|
4 Participants
|
0 Participants
|
|
Best Overall Response (Investigator Assessment)
PR
|
16 Participants
|
1 Participants
|
|
Best Overall Response (Investigator Assessment)
MR
|
31 Participants
|
0 Participants
|
|
Best Overall Response (Investigator Assessment)
SD
|
61 Participants
|
31 Participants
|
|
Best Overall Response (Investigator Assessment)
PD
|
37 Participants
|
39 Participants
|
|
Best Overall Response (Investigator Assessment)
NE
|
22 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsIncludes sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Response Rate (Investigator Assessment)
|
29.8 percentage of participants
Interval 23.1 to 37.3
|
1.2 percentage of participants
Interval 0.03 to 6.5
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the date of disease progression or death, assessed up to 5 yearsVery good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas
Outcome measures
| Measure |
Plitidepsin+Dexamethasone
n=171 Participants
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=84 Participants
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Overall Response Rate (Investigator Assessment) Excluding MR
|
11.7 percentage of participants
Interval 7.3 to 17.5
|
1.2 percentage of participants
Interval 0.03 to 6.5
|
Adverse Events
Plitidepsin+Dexamethasone
Serious events: 99 serious events
Other events: 161 other events
Deaths: 126 deaths
Dexamethasone
Serious events: 26 serious events
Other events: 80 other events
Deaths: 74 deaths
Serious adverse events
| Measure |
Plitidepsin+Dexamethasone
n=167 participants at risk
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=83 participants at risk
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
2/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Deep vein thrombosis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Hypotension
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Vena cava thrombosis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Venous thrombosis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmablastic lymphoma
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Asthenia
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Fatigue
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
General physical health deterioration
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Malaise
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Multi-organ failure
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Pain
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Pyrexia
|
4.8%
8/167 • Number of events 8 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Thrombosis in device
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Sudden death
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Psychiatric disorders
Confusional state
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Psychiatric disorders
Delirium
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Psychiatric disorders
Psychotic disorder
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Alanine aminotransferase increased
|
4.2%
7/167 • Number of events 10 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Aspartate aminotransferase increased
|
3.6%
6/167 • Number of events 12 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Blood alkaline phosphatase increased
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Blood creatine phosphokinase increased
|
3.6%
6/167 • Number of events 9 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Electrocardiogram QT prolonged
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.2%
2/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Hepatic enzyme abnormal
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Troponin I increased
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Weight decreased
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Plasma cells increased
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
2/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Cardiac failure
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Cardiac failure congestive
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Myocardial infarction
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Systolic dysfunction
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.2%
2/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
3/167 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Hyperviscosity syndrome
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Cerebrovascular accident
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Headache
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Paraplegia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Paresis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Presyncope
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Quadriparesis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Somnolence
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Spinal cord compression
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Syncope
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Enteritis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Ileus
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Nausea
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
6/167 • Number of events 8 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Renal and urinary disorders
Haematuria
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Renal and urinary disorders
Renal failure
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Hepatobiliary disorders
Cholangitis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Hepatobiliary disorders
Cholestasis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.6%
6/167 • Number of events 7 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Atypical pneumonia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Bacteraemia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Bronchitis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Bronchopneumonia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Cellulitis
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Clostridium difficile colitis
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Device related infection
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Device related sepsis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Enterocolitis infectious
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Escherichia sepsis
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Gastroenteritis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Gastroenteritis viral
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Herpes zoster
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Infection
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Lobar pneumonia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Lower respiratory tract infection
|
0.60%
1/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Lung infection
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Neutropenic sepsis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pneumonia
|
9.0%
15/167 • Number of events 18 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pneumonia fungal
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pneumonia pneumococcal
|
1.2%
2/167 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pseudomonas infection
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Respiratory tract infection
|
1.8%
3/167 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Sepsis
|
5.4%
9/167 • Number of events 9 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Septic shock
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Upper respiratory tract infection
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Urinary tract infection
|
2.4%
4/167 • Number of events 4 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Urosepsis
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Viral infection
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Clostridium colitis
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/167 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Clostridium difficile infection
|
0.60%
1/167 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
Other adverse events
| Measure |
Plitidepsin+Dexamethasone
n=167 participants at risk
plitidepsin + dexamethasone combination
plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
|
Dexamethasone
n=83 participants at risk
dexamethasone single agent
dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
|
|---|---|---|
|
Vascular disorders
Hypertension
|
8.4%
14/167 • Number of events 17 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 6 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Vascular disorders
Hypotension
|
9.6%
16/167 • Number of events 17 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Alanine aminotransferase increased
|
13.2%
22/167 • Number of events 48 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Aspartate aminotransferase increased
|
6.6%
11/167 • Number of events 20 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Blood creatine phosphokinase increased
|
16.8%
28/167 • Number of events 41 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
0.00%
0/83 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Electrocardiogram QT prolonged
|
9.0%
15/167 • Number of events 34 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Weight decreased
|
7.2%
12/167 • Number of events 13 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Investigations
Platelet count decreased
|
4.2%
7/167 • Number of events 67 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 21 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
31/167 • Number of events 42 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
10.8%
9/83 • Number of events 10 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.8%
23/167 • Number of events 36 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.0%
10/167 • Number of events 11 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
7.2%
6/83 • Number of events 8 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Anaemia
|
41.3%
69/167 • Number of events 203 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
41.0%
34/83 • Number of events 97 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.2%
12/167 • Number of events 26 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.0%
15/167 • Number of events 47 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
9.6%
8/83 • Number of events 15 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Nervous system disorders
Headache
|
10.8%
18/167 • Number of events 18 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 6 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Asthenia
|
19.2%
32/167 • Number of events 60 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
10.8%
9/83 • Number of events 11 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Chest pain
|
5.4%
9/167 • Number of events 12 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Fatigue
|
32.9%
55/167 • Number of events 95 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
21.7%
18/83 • Number of events 22 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Oedema peripheral
|
18.6%
31/167 • Number of events 45 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 6 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
General disorders
Pyrexia
|
19.2%
32/167 • Number of events 50 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
13.3%
11/83 • Number of events 14 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Psychiatric disorders
Insomnia
|
10.8%
18/167 • Number of events 23 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
12.0%
10/83 • Number of events 11 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.6%
16/167 • Number of events 16 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Constipation
|
12.6%
21/167 • Number of events 23 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 7 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Diarrhoea
|
34.1%
57/167 • Number of events 80 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
9.6%
8/83 • Number of events 10 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Dyspepsia
|
5.4%
9/167 • Number of events 12 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
4.8%
4/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Nausea
|
45.5%
76/167 • Number of events 122 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
20.5%
17/83 • Number of events 19 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Gastrointestinal disorders
Vomiting
|
24.6%
41/167 • Number of events 57 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
8/167 • Number of events 8 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
7.2%
6/83 • Number of events 6 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
16/167 • Number of events 18 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
18.1%
15/83 • Number of events 22 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.2%
12/167 • Number of events 13 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
18.1%
15/83 • Number of events 17 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.6%
21/167 • Number of events 27 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.2%
12/167 • Number of events 14 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
1.2%
1/83 • Number of events 1 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
18.0%
30/167 • Number of events 47 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.4%
34/167 • Number of events 40 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.8%
8/167 • Number of events 9 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
8.4%
7/83 • Number of events 11 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.6%
11/167 • Number of events 16 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
3.6%
3/83 • Number of events 3 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
19/167 • Number of events 23 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Nasopharyngitis
|
3.0%
5/167 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Upper respiratory tract infection
|
8.4%
14/167 • Number of events 19 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
6.0%
5/83 • Number of events 5 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
|
Infections and infestations
Urinary tract infection
|
7.2%
12/167 • Number of events 13 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
2.4%
2/83 • Number of events 2 • From first infusion to 30 days after the last administration of trial drug and until their resolution, an average of 5 years
Four patients were not treated after randomization in Plitidepsin+Dexamethasone due to 2 deaths, 1 patient refusal and 1 reason not specified. One patient was not treated after randomization in Dexamethasone due to patient refusal
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.
- Publication restrictions are in place
Restriction type: OTHER