Trial Outcomes & Findings for A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients (NCT NCT01951157)
NCT ID: NCT01951157
Last Updated: 2019-09-24
Results Overview
The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after randomization. Progession disease was defined as 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. The appearance of one or more new lesions was also considered progression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
At month four after patient inclusion
Results posted on
2019-09-24
Participant Flow
69 patients were enrolled between 11/09/2013 and 2/10/2015 at 13 centers. 68 patients were treated: 22 in Arm A, 21 in Arm B, and 25 in Arm C. The first dose of the first cycle was administered on 17/09/2013 and the last dose of the last cycle was administered on 3/11/2016. The last patient, last follow-up was on 24/11/2016
Participant milestones
| Measure |
A - Docetaxel
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
25
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
22
|
25
|
Reasons for withdrawal
| Measure |
A - Docetaxel
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Overall Study
Progressive Disease
|
12
|
13
|
10
|
|
Overall Study
Treatment-unrelated AE
|
1
|
0
|
3
|
|
Overall Study
Study Termination
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
5
|
3
|
2
|
|
Overall Study
Non-treatmentrelated death
|
2
|
2
|
2
|
|
Overall Study
No treated
|
0
|
1
|
0
|
|
Overall Study
Treatment-related AE
|
2
|
0
|
4
|
|
Overall Study
Consent withdrawn by subject
|
0
|
1
|
3
|
|
Overall Study
Treatment-related death
|
0
|
2
|
0
|
Baseline Characteristics
A Clinical Study in Three-arm of Lurbinectedin (PM01183) Alone or in Combination With Gemcitabine and a Control Arm With Docetaxel as Second Line Treatment in Non-Small Cell Lung Cancer (NSCLC) Patients
Baseline characteristics by cohort
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=22 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=25 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Age, Continuous
|
61.5 years
n=99 Participants
|
65 years
n=107 Participants
|
64 years
n=206 Participants
|
63 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Region of Enrollment
Italy
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
12 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
ECOG PS
PS 0
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
ECOG PS
PS 1
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
42 Participants
n=7 Participants
|
|
Histology type
Non-squamous-cell
|
17 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
|
Histology type
Squamous-cell
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Histology type
Not specified
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Histology grade
Well differentiated
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Histology grade
Moderately differentiated
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Histology grade
Poorly differentiated
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Histology grade
Unknown
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
|
Stage at diagnosis
Early
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Stage at diagnosis
Locally advanced
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Stage at diagnosis
Metastatic
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
47 Participants
n=7 Participants
|
|
Stage at diagnosis
Unknown
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Stage at study entry
Locally advanced
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Stage at study entry
Metastatic
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
66 Participants
n=7 Participants
|
|
Surgery
Yes
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
|
Surgery
No
|
19 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Radiotherapy
Yes
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
|
Radiotherapy
No
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
|
Prior chemotherapy
1 line
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
63 Participants
n=7 Participants
|
|
Prior chemotherapy
2 lines
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Best response to last prior platinum
PR
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
|
Best response to last prior platinum
SD
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Best response to last prior platinum
PD
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Best response to last prior platinum
NA
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Best response to last prior platinum
UK
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Weight
|
70.5 Kg
n=99 Participants
|
74 Kg
n=107 Participants
|
77 Kg
n=206 Participants
|
73.6 Kg
n=7 Participants
|
|
Body Surface Area
|
1.8 m^2
n=99 Participants
|
1.9 m^2
n=107 Participants
|
1.9 m^2
n=206 Participants
|
1.8 m^2
n=7 Participants
|
|
Signs and symptoms per patient
|
1 Signs and symptoms
n=99 Participants
|
1 Signs and symptoms
n=107 Participants
|
1 Signs and symptoms
n=206 Participants
|
1 Signs and symptoms
n=7 Participants
|
|
Albumin
|
4.3 g/dL
n=99 Participants
|
3.9 g/dL
n=107 Participants
|
4 g/dL
n=206 Participants
|
4 g/dL
n=7 Participants
|
|
Alpha-1-acid glycoprotein
|
172 mg/dL
n=99 Participants
|
141 mg/dL
n=107 Participants
|
159 mg/dL
n=206 Participants
|
161 mg/dL
n=7 Participants
|
|
Time from first diagnosis to first infusion
|
8 months
n=99 Participants
|
11.4 months
n=107 Participants
|
9.2 months
n=206 Participants
|
9.8 months
n=7 Participants
|
|
Number of sites involved at baseline
|
3 sites
n=99 Participants
|
3 sites
n=107 Participants
|
3 sites
n=206 Participants
|
3 sites
n=7 Participants
|
|
Platinum-free interval
|
3.5 months
n=99 Participants
|
5.6 months
n=107 Participants
|
3.9 months
n=206 Participants
|
4.4 months
n=7 Participants
|
|
PFS to last prior line
|
5.7 mohths
n=99 Participants
|
6.7 mohths
n=107 Participants
|
5.4 mohths
n=206 Participants
|
5.8 mohths
n=7 Participants
|
PRIMARY outcome
Timeframe: At month four after patient inclusionPopulation: Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment
The rate estimate of the percentage of patients who are alive and progression-free at 16 weeks (\~4 months) after randomization. Progession disease was defined as 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. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Progression-free Survival Rate at Four Months (PFS4)
|
27.3 percentage of participants
Interval 10.7 to 50.2
|
15.8 percentage of participants
Interval 3.4 to 39.6
|
26.1 percentage of participants
Interval 10.2 to 48.4
|
SECONDARY outcome
Timeframe: Time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation, whichever came first, assessed up to 3 yearsPopulation: B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment
PFS, progression-free survival Progression-free survival (PFS), defined as the time from the date of randomization to the date of PD, death (of any cause), or last tumor evaluation. Progession disease was defined as 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. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Progression-free Survival
|
3.1 months
Interval 1.8 to 4.0
|
1.9 months
Interval 1.5 to 3.0
|
3.3 months
Interval 1.9 to 5.7
|
SECONDARY outcome
Timeframe: At month six after patient inclusionPopulation: B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment
The rate estimate of the percentage of patients who are alive and progression-free at 24 weeks (\~6 months) after randomization. Progession disease was defined as 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. The appearance of one or more new lesions was also considered progression.
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Progression-free Survival Rate at Six Months (PFS6)
|
18.2 percentage of participants
Interval 2.1 to 34.3
|
16.7 percentage of participants
Interval 0.0 to 33.9
|
17.5 percentage of participants
Interval 0.0 to 35.2
|
SECONDARY outcome
Timeframe: Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 yearsPopulation: B - 1 no treated, 1 no tumour assesment, 1 major protocol deviation C - 2 no tumour assesment
Overall response rate (ORR) was defined as the percentage of patients with a response, either CR or PR, according to RECIST v.1.1. 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.
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Overall Response Rate
|
9.1 percentage of participants
Interval 1.1 to 29.2
|
0 percentage of participants
Interval 0.0 to 17.6
|
17.4 percentage of participants
Interval 5.0 to 38.8
|
SECONDARY outcome
Timeframe: Time from the date of randomization until 30±7 days after the last treatment infusion, assessed up to 3 yearsPopulation: B- 1 no treated, 1 no tumour assesment, 1 major protocol deviation C- 2 no tumour assesment
RECIST, Response Evaluation Criteria In Solid Tumors Complete Response (CR) Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10mm 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Appearance of new lesions was considered PD 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 Treatment failure (TF) Symptomatic deterioration/death due to progression or treatment discontinuation due to treatment-related toxicity occurred before any appropriate tumor assessments had been performed
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Objective Response Per RECIST v.1.1
PR
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Objective Response Per RECIST v.1.1
SD
|
10 Participants
|
7 Participants
|
11 Participants
|
|
Objective Response Per RECIST v.1.1
PD
|
8 Participants
|
8 Participants
|
6 Participants
|
|
Objective Response Per RECIST v.1.1
TF
|
2 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: The time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented, up to 3 yearsPopulation: Two patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm A. No patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm B. Four patients with CR or PR to treatment as per the RECIST v.1.1 criteria were found in Arm C.
Duration of response (DR) was defined as the time from the date when the response criteria (PR or CR, whichever was reached first) were fulfilled, to the first date when PD, recurrence or death was documented. 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.
Outcome measures
| Measure |
A - Docetaxel
n=2 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=4 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Duration of Response
|
1.2 months
Interval 0.8 to 1.6
|
—
|
6.1 months
Interval 2.0 to
upper limit was not estimable due to few participants with events
|
SECONDARY outcome
Timeframe: From the date of first infusion to the date of death or last contact, up to 12 months after last patient inclusionPopulation: Arm B: 1 no treated, 1 no tumour assesment, 1 major protocol deviation Arm C: 2 no tumour assesment
Overall survival (OS) will be defined as time from the date of first infusion to the date of death or last contact
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=19 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=23 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Overall Survival (OS)
|
9.4 months
Interval 3.1 to
upper limit was not estimable due to few participants with events
|
5.5 months
Interval 3.0 to 8.0
|
7.2 months
Interval 4.5 to 10.6
|
SECONDARY outcome
Timeframe: Baseline, Cycle 3 (~9 weeks), Cycle 6 (~18 weeks) and Cycle 9 (~27 weeks)Population: No patients in cycle 9 in arm A and arm C.
The mean QoL scores self-reported by patients using the Lung Cancer Symptom Scale (LCSS) at baseline and after the start of the therapy in visits 3 or 6 (+/- 1 visit) and visit 9 for those patients in maintenance therapy. Higher LCSS scores indicate more severe problems and the scale range is (0-100) Total score was calculated as the mean of the total scores of all nine patient ítems (Appetite, Fatigue, Cough, Dyspnea, Hemoptysis, Pain, Lung cancer symptoms, Normal activities, Global QoL)
Outcome measures
| Measure |
A - Docetaxel
n=22 Participants
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=20 Participants
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amendment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=25 Participants
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amendment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Information on Quality of Life (QoL)
Cycle 3
|
29.5 units on a scale
Interval 14.5 to 44.5
|
32.2 units on a scale
Interval 19.5 to 44.9
|
36.4 units on a scale
Interval 25.4 to 47.5
|
|
Information on Quality of Life (QoL)
Baseline
|
27.2 units on a scale
Interval 18.4 to 36.1
|
36.4 units on a scale
Interval 25.0 to 47.7
|
38.1 units on a scale
Interval 27.7 to 48.5
|
|
Information on Quality of Life (QoL)
Cycle 6
|
24.3 units on a scale
Interval 17.4 to 31.1
|
55.4 units on a scale
95%CI was not calculated due to only one patient was evaluated
|
35.4 units on a scale
Interval -11.7 to 82.5
|
|
Information on Quality of Life (QoL)
Cycle 9
|
—
|
38.1 units on a scale
Interval -74.8 to 151.1
|
—
|
Adverse Events
A - Docetaxel
Serious events: 12 serious events
Other events: 21 other events
Deaths: 14 deaths
B - Lurbinectedin (PM01183)
Serious events: 9 serious events
Other events: 20 other events
Deaths: 17 deaths
C - Gemcitabine + Lurbinectedin (PM01183)
Serious events: 18 serious events
Other events: 25 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
A - Docetaxel
n=22 participants at risk
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=21 participants at risk
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=25 participants at risk
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Vascular disorders
Shock
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Vascular disorders
Thrombosis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Death
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Asthenia/Fatigue
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
General physical health deterioration
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Injury, poisoning and procedural complications
Femur fracture
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Investigations
Platelet count decreased
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 8 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Investigations
Transaminases increased
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Cardiac disorders
Myocardial infarction
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.5%
1/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Renal and urinary disorders
Renal injury
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Necrotising fasciitis
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Pneumonia
|
13.6%
3/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
16.0%
4/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Septic shock
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Fungal infection
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Bronchitis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Lung infection
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
Other adverse events
| Measure |
A - Docetaxel
n=22 participants at risk
75 mg/m2 docetaxel day 1, 1-hour intravenous, every three weeks
Docetaxel: Powder for solution for infusion
|
B - Lurbinectedin (PM01183)
n=21 participants at risk
In the first protocol version, PM01183 7 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles After protocol amedment 3, PM01183 3.2 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
C - Gemcitabine + Lurbinectedin (PM01183)
n=25 participants at risk
Gemcitabine 800 mg/m2, 30-min i.v. infusion, immediately followed by PM01183 3.0 mg Flat dose, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (in the first protocol version) or PM01183 1.6 mg/m2, 1-h i.v. infusion (at a fixed rate), on D1, q3wk, up to 6 cycles (after protocol amedment 3)
Gemcitabine: Powder for solution for infusion
Lurbinectedin (PM01183): Powder for concentrate for solution for infusion
|
|---|---|---|---|
|
Vascular disorders
Phlebitis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 6 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Vascular disorders
Hypertension
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Vascular disorders
Hypotension
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Asthenia/Fatigue
|
72.7%
16/22 • Number of events 30 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
76.2%
16/21 • Number of events 32 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
68.0%
17/25 • Number of events 35 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Mucosal inflammation
|
18.2%
4/22 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Oedema peripheral
|
18.2%
4/22 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
20.0%
5/25 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Pyrexia
|
31.8%
7/22 • Number of events 10 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
23.8%
5/21 • Number of events 8 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
28.0%
7/25 • Number of events 14 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
Chest pain
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
General disorders
General physical health deterioration
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Investigations
Platelet count decreased
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 6 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
16.0%
4/25 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Investigations
Weight decreased
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Anaemia
|
13.6%
3/22 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
33.3%
7/21 • Number of events 11 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
60.0%
15/25 • Number of events 29 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
4/22 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 8 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
52.0%
13/25 • Number of events 21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
16.0%
4/25 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
36.4%
8/22 • Number of events 13 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
23.8%
5/21 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
16.0%
4/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
36.4%
8/22 • Number of events 11 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
23.8%
5/21 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
28.0%
7/25 • Number of events 9 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Nervous system disorders
Dysgeusia
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Nervous system disorders
Neuropathy peripheral
|
18.2%
4/22 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Eye disorders
Conjunctivitis
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
23.8%
5/21 • Number of events 6 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
24.0%
6/25 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
3/22 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
16.0%
4/25 • Number of events 10 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
28.6%
6/21 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
52.0%
13/25 • Number of events 23 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Stomatitis
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
2/22 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
38.1%
8/21 • Number of events 10 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
24.0%
6/25 • Number of events 13 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
28.6%
6/21 • Number of events 7 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.6%
3/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.8%
1/21 • Number of events 5 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 4 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
2/22 • Number of events 6 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
12.0%
3/25 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
47.6%
10/21 • Number of events 13 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
32.0%
8/25 • Number of events 10 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
2/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
14.3%
3/21 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
9.5%
2/21 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Lung infection
|
9.1%
2/22 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/25 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Respiratory tract infection
|
9.1%
2/22 • Number of events 3 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
4.0%
1/25 • Number of events 1 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/22 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
0.00%
0/21 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
8.0%
2/25 • Number of events 2 • Participants were assessed through study completion, approximately 3 years
All 68 treated patients were evaluable for safety: 22 in Arm A (docetaxel), 21 in Arm B (PM01183) and 25 in Arm C (gemcitabine/PM01183). One Patient in Arm B was never treated due to patient's refusal, therefore, this patient was excluded of the safety population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review
- Publication restrictions are in place
Restriction type: OTHER