Trial Outcomes & Findings for Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors (NCT NCT02533674)
NCT ID: NCT02533674
Last Updated: 2021-06-11
Results Overview
Dose-limiting toxicities were defined as: * Grade 4 neutropenia lasting \>3 days * Grade≥3 febrile neutropenia of any duration or neutropenic sepsis * Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion * Grade 4 ALT/AST increase, or grade 3 lasting \>7 days * Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP * Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities * Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs. * The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
57 participants
Primary outcome timeframe
From the start of treatment to the end of cycle one which are 3 weeks
Results posted on
2021-06-11
Participant Flow
A total of 57 patients were enrolled at three investigational sites, and 55 patients were treated with the GEM/PM060184 combination. Two patients were never treated. Patients participated in this trial between 12 December 2014 and 11 July 2019 (last follow-up). The first dose of the first cycle was given on 10 February 2015 and the last dose of the last cycle was given on 7 June 2019.
Participant milestones
| Measure |
GEM/PM060184 Dose Level I
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Dose Level I
STARTED
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
NOT COMPLETED
|
5
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
STARTED
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
NOT COMPLETED
|
0
|
7
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
STARTED
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
NOT COMPLETED
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level IV
STARTED
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Dose Level IV
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level IV
NOT COMPLETED
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
Dose Level V
STARTED
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Dose Level V
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level V
NOT COMPLETED
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
|
Dose Level VI
STARTED
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
|
Dose Level VI
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level VI
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
9
|
0
|
0
|
|
Dose Level VII
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Dose Level VII
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level VII
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
0
|
|
Dose Level VIII
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
|
Dose Level VIII
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level VIII
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
GEM/PM060184 Dose Level I
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Dose Level I
Progressive disease
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
Death
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level I
Never Treated
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
Progressive disease
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
Treatment-related AE
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level II
Non-treatment-related AE
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
Progressive disease
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level III
Treatment-related AE
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Dose Level IV
Progressive disease
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Dose Level IV
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dose Level IV
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Dose Level V
Progressive disease
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Dose Level V
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Level V
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Dose Level VI
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
|
Dose Level VI
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Level VI
Treatment-related AE
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Dose Level VII
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
0
|
|
Dose Level VII
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
|
Dose Level VII
Treatment-related AE
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Dose Level VII
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Dose Level VIII
Progressive disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Dose Level VIII
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Level VIII
Treatment-related AE
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Dose Level VIII
Never treated
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Multicenter, Open-label, Clinical and Pharmacokinetic Study of PM060184 in Combination With Gemcitabine in Selected Patients With Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
GEM/PM060184 Dose Level I
n=5 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
n=7 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
n=4 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
n=5 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
n=5 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
n=9 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
n=16 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
n=6 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
67.0 years
n=7 Participants
|
58.5 years
n=5 Participants
|
65.0 years
n=4 Participants
|
68.0 years
n=21 Participants
|
62.0 years
n=10 Participants
|
59.0 years
n=115 Participants
|
49.0 years
n=24 Participants
|
62.0 years
n=42 Participants
|
|
Age, Customized
18-55
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
19 Participants
n=42 Participants
|
|
Age, Customized
56-75
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
35 Participants
n=42 Participants
|
|
Age, Customized
>75
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
26 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Not provided/not available
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
3 participants
n=21 Participants
|
5 participants
n=10 Participants
|
12 participants
n=115 Participants
|
4 participants
n=24 Participants
|
36 participants
n=42 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
4 participants
n=10 Participants
|
4 participants
n=115 Participants
|
2 participants
n=24 Participants
|
21 participants
n=42 Participants
|
|
ECOG PS
0
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
15 Participants
n=42 Participants
|
|
ECOG PS
1
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
3 Participants
n=24 Participants
|
42 Participants
n=42 Participants
|
|
Body surface area
|
1.6 m^2
n=5 Participants
|
1.7 m^2
n=7 Participants
|
2.0 m^2
n=5 Participants
|
1.7 m^2
n=4 Participants
|
1.9 m^2
n=21 Participants
|
1.8 m^2
n=10 Participants
|
1.8 m^2
n=115 Participants
|
1.6 m^2
n=24 Participants
|
1.8 m^2
n=42 Participants
|
|
Tumor type
NSCLC
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Tumor type
Gynecological (endometrial or cervical)
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Tumor type
Epithelial ovarian cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
13 Participants
n=42 Participants
|
|
Tumor type
Breast cancer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
|
Tumor type
GIST
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Tumor type
Head and neck cancer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Tumor type
GCTs
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
|
Tumor type
Adenocarcinoma or carcinoma of unknown primary site
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
|
Time from diagnosis to first infusion
|
30.2 months
n=5 Participants
|
43.0 months
n=7 Participants
|
23.2 months
n=5 Participants
|
34.3 months
n=4 Participants
|
23.4 months
n=21 Participants
|
33.9 months
n=10 Participants
|
44.5 months
n=115 Participants
|
48.8 months
n=24 Participants
|
48.8 months
n=42 Participants
|
|
Time from last progressive disease to first infusion
|
1.6 months
n=5 Participants
|
1.0 months
n=7 Participants
|
2.2 months
n=5 Participants
|
1.7 months
n=4 Participants
|
1.4 months
n=21 Participants
|
2.4 months
n=10 Participants
|
1.2 months
n=115 Participants
|
0.7 months
n=24 Participants
|
1.4 months
n=42 Participants
|
|
Time-to-progression of last prior therapy
|
1.6 months
n=5 Participants
|
3.8 months
n=7 Participants
|
3.4 months
n=5 Participants
|
6.7 months
n=4 Participants
|
11.7 months
n=21 Participants
|
5.4 months
n=10 Participants
|
3.0 months
n=115 Participants
|
2.9 months
n=24 Participants
|
3.7 months
n=42 Participants
|
|
Bulky disease
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
|
Site involvement at baseline
|
3 sites
n=5 Participants
|
4 sites
n=7 Participants
|
4.5 sites
n=5 Participants
|
3 sites
n=4 Participants
|
3 sites
n=21 Participants
|
4 sites
n=10 Participants
|
4 sites
n=115 Participants
|
3.5 sites
n=24 Participants
|
4 sites
n=42 Participants
|
|
Lines of prior anticancer therapies
|
2 lines
n=5 Participants
|
3 lines
n=7 Participants
|
3 lines
n=5 Participants
|
2 lines
n=4 Participants
|
3 lines
n=21 Participants
|
3 lines
n=10 Participants
|
3 lines
n=115 Participants
|
3.5 lines
n=24 Participants
|
3 lines
n=42 Participants
|
|
Agents of prior anticancer therapies
|
4 Agents
n=5 Participants
|
4 Agents
n=7 Participants
|
4.5 Agents
n=5 Participants
|
5 Agents
n=4 Participants
|
3 Agents
n=21 Participants
|
3 Agents
n=10 Participants
|
4.5 Agents
n=115 Participants
|
5 Agents
n=24 Participants
|
4 Agents
n=42 Participants
|
PRIMARY outcome
Timeframe: From the start of treatment to the end of cycle one which are 3 weeksPopulation: Thirteen patients were not evaluable: 11 patients because they did not complete Cycle 1, and two patients because they were withdrawn from the study before receiving the first study drug infusion.
Dose-limiting toxicities were defined as: * Grade 4 neutropenia lasting \>3 days * Grade≥3 febrile neutropenia of any duration or neutropenic sepsis * Grade 4 thrombocytopenia or grade 3 with any major bleeding episode requiring a platelet transfusion * Grade 4 ALT/AST increase, or grade 3 lasting \>7 days * Treatment-related grade≥2 ALT/AST increase concomitantly with ≥2 x ULN total bilirubin increase and normal AP * Any other grade≥3 non-hematological AE that was suspected to be related to study drugs, except nausea/vomiting, hypersensitivity reactions, extravasations, grade 3 asthenia lasting less than one week, anorexia, and non-clinically relevant isolated biochemical abnormalities * Delay in the administration of Cycle 2 of the combination exceeding seven (+1) days of the treatment due date due to any AEs related to study drugs. * The following circumstances were to be discussed between the Principal Investigator and the Sponsor, and the final consensus had to be documented
Outcome measures
| Measure |
GEM/PM060184 Dose Level I
n=3 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
n=6 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
n=3 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
n=3 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
n=4 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
n=7 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
n=13 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
n=5 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Every two cycles (every six weeks ± one week) until Cycle 4, and then every three cycles (every nine weeks ± one week) while on treatment, up to 2 yearsPopulation: Eleven patients were not evaluable: nine patients because they were withdrawn from the study before undergoing a tumor assessment, and two patients because they were withdrawn from the study before receiving the first study drug infusion
Clinical benefit defined as any response or stable disease ≥4 months. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
GEM/PM060184 Dose Level I
n=4 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
n=6 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
n=3 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
n=4 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
n=4 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
n=9 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
n=11 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
n=5 Participants
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Benefit
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
GEM/PM060184 Dose Level I
Serious events: 2 serious events
Other events: 4 other events
Deaths: 1 deaths
GEM/PM060184 Dose Level II
Serious events: 3 serious events
Other events: 7 other events
Deaths: 1 deaths
GEM/PM060184 Dose Level III
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
GEM/PM060184 Dose Level IV
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
GEM/PM060184 Dose Level V
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
GEM/PM060184 Dose Level VI
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
GEM/PM060184 Dose Level VII
Serious events: 8 serious events
Other events: 16 other events
Deaths: 5 deaths
GEM/PM060184 Dose Level VIII
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GEM/PM060184 Dose Level I
n=4 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
n=7 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
n=4 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
n=9 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
n=16 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Chills
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
Other adverse events
| Measure |
GEM/PM060184 Dose Level I
n=4 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level I: 800 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level II
n=7 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level II: 800 mg/m\^2 GEM / 7.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level III
n=4 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level III: 1000 mg/m\^2 GEM / 6.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level IV
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level IV: 1000 mg/m\^2 GEM / 8.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level V
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level V: 1000 mg/m\^2 GEM / 9.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VI
n=9 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VI: 1000 mg/m\^2 GEM / 9.3 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VII
n=16 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VII:1000 mg/m\^2 GEM / 10.0 mg/m\^2 PM060184
|
GEM/PM060184 Dose Level VIII
n=5 participants at risk
Patients were to receive GEM first, followed by PM060184, both on Day 1 and Day 8 q3wk.
Administration of study treatment was as follows:
* GEM: i.v. infusion over 30 min (± 10 min) via a central or peripheral venous catheter through a pump device, followed by:
* PM060184: i.v. infusion over 10 min (± 3 min) via a central or peripheral venous catheter through a pump device.
Dose Level VIII:1000 mg/m\^2 GEM / 10.5 mg/m\^2 PM060184
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Pollakiuria
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Urethritis noninfective
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Vulvovaginal pruritus
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Asthenia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
44.4%
4/9 • Number of events 9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
71.4%
5/7 • Number of events 11 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
75.0%
3/4 • Number of events 8 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 6 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 12 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
62.5%
10/16 • Number of events 27 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 8 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Catheter site erythema
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Local swelling
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Gait disturbance
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Chills
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Infusion site discolouration
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Malaise
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Oedema
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
General disorders
Catheter site pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Weight decreased
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
28.6%
2/7 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
50.0%
8/16 • Number of events 10 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Blood urine present
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Weight increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Anaemia
|
50.0%
2/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
28.6%
2/7 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
50.0%
2/4 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
33.3%
3/9 • Number of events 14 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
43.8%
7/16 • Number of events 28 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 6 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Neutropenia
|
75.0%
3/4 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 6 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Paraesthesia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 12 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
37.5%
6/16 • Number of events 9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
4/16 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Nervous system disorders
Syncope
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Eye disorders
Cataract
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
37.5%
6/16 • Number of events 9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 6 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
44.4%
4/9 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
50.0%
8/16 • Number of events 13 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
80.0%
4/5 • Number of events 9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
28.6%
2/7 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
50.0%
8/16 • Number of events 20 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
71.4%
5/7 • Number of events 7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
80.0%
4/5 • Number of events 8 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
44.4%
4/9 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
68.8%
11/16 • Number of events 17 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
80.0%
4/5 • Number of events 8 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
42.9%
3/7 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
37.5%
6/16 • Number of events 9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 13 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
18.8%
3/16 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
12.5%
2/16 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
40.0%
2/5 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
22.2%
2/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
68.8%
11/16 • Number of events 21 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
60.0%
3/5 • Number of events 3 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
14.3%
1/7 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
25.0%
1/4 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
20.0%
1/5 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 2 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
11.1%
1/9 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/16 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Device related infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/7 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/4 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/9 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
6.2%
1/16 • Number of events 1 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
0.00%
0/5 • Participants were assessed through study completion, approximately 2 years
Two patients were never treated with plitidepsin and were excluded from the analysis of safety.
|
Additional Information
Clinical Developtment, Department of PharmaMar´s Oncology., Business Unit.
Pharma Mar, S.A.
Phone: +34 918466000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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