Trial Outcomes & Findings for PembROlizuMab Immunotherapy Versus Standard Chemotherapy for Advanced prE-treated Malignant Pleural Mesothelioma (NCT NCT02991482)
NCT ID: NCT02991482
Last Updated: 2022-08-24
Results Overview
To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
144 participants
Primary outcome timeframe
Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).
Results posted on
2022-08-24
Participant Flow
Participant milestones
| Measure |
Pembrolizumab Arm
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
71
|
|
Overall Study
Crossed-over to Pembrolizumab at Progression
|
0
|
45
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
65
|
66
|
Reasons for withdrawal
| Measure |
Pembrolizumab Arm
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Overall Study
Disease progression
|
56
|
47
|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Adverse Event
|
1
|
6
|
|
Overall Study
Patient decision
|
1
|
1
|
|
Overall Study
Physician Decision
|
0
|
6
|
|
Overall Study
Clinical deterioration
|
1
|
0
|
|
Overall Study
Patient feeling too unwell
|
1
|
0
|
|
Overall Study
Worsening of performance status
|
0
|
1
|
|
Overall Study
Death prior to study drug initiation
|
1
|
0
|
|
Overall Study
Consent withdrawal prior to study drug initiation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
PD-L1 Tumour proportion score
≥20%
|
11 Participants
n=73 Participants
|
14 Participants
n=71 Participants
|
25 Participants
n=144 Participants
|
|
Age, Continuous
|
69.0 years
n=73 Participants
|
71.0 years
n=71 Participants
|
70.0 years
n=144 Participants
|
|
Age, Customized
Age category · <70 years
|
42 Participants
n=73 Participants
|
29 Participants
n=71 Participants
|
71 Participants
n=144 Participants
|
|
Age, Customized
Age category · ≥70 years
|
31 Participants
n=73 Participants
|
42 Participants
n=71 Participants
|
73 Participants
n=144 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=73 Participants
|
11 Participants
n=71 Participants
|
26 Participants
n=144 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=73 Participants
|
60 Participants
n=71 Participants
|
118 Participants
n=144 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
54 Participants
n=73 Participants
|
53 Participants
n=71 Participants
|
107 Participants
n=144 Participants
|
|
Region of Enrollment
Switzerland
|
13 Participants
n=73 Participants
|
14 Participants
n=71 Participants
|
27 Participants
n=144 Participants
|
|
Region of Enrollment
Spain
|
6 Participants
n=73 Participants
|
4 Participants
n=71 Participants
|
10 Participants
n=144 Participants
|
|
Histologic subtype
Epithelioid
|
66 Participants
n=73 Participants
|
62 Participants
n=71 Participants
|
128 Participants
n=144 Participants
|
|
Histologic subtype
Non-epithelioid
|
7 Participants
n=73 Participants
|
9 Participants
n=71 Participants
|
16 Participants
n=144 Participants
|
|
Smoking history
Current
|
5 Participants
n=73 Participants
|
4 Participants
n=71 Participants
|
9 Participants
n=144 Participants
|
|
Smoking history
Former (≥100 cigarettes in the past during the whole life)
|
34 Participants
n=73 Participants
|
28 Participants
n=71 Participants
|
62 Participants
n=144 Participants
|
|
Smoking history
Never (0-99 cigarettes during the whole life)
|
33 Participants
n=73 Participants
|
39 Participants
n=71 Participants
|
72 Participants
n=144 Participants
|
|
Smoking history
Unknown/Missing
|
1 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=144 Participants
|
|
ECOG performance status
0
|
21 Participants
n=73 Participants
|
14 Participants
n=71 Participants
|
35 Participants
n=144 Participants
|
|
ECOG performance status
1
|
51 Participants
n=73 Participants
|
57 Participants
n=71 Participants
|
108 Participants
n=144 Participants
|
|
ECOG performance status
2
|
1 Participants
n=73 Participants
|
0 Participants
n=71 Participants
|
1 Participants
n=144 Participants
|
|
EORTC score
Good prognosis
|
45 Participants
n=73 Participants
|
54 Participants
n=71 Participants
|
99 Participants
n=144 Participants
|
|
EORTC score
Poor prognosis
|
28 Participants
n=73 Participants
|
17 Participants
n=71 Participants
|
45 Participants
n=144 Participants
|
|
Prior treatment
Carboplatin/Pemetrexed
|
27 Participants
n=73 Participants
|
27 Participants
n=71 Participants
|
54 Participants
n=144 Participants
|
|
Prior treatment
Cisplatin/Pemetrexed
|
24 Participants
n=73 Participants
|
22 Participants
n=71 Participants
|
46 Participants
n=144 Participants
|
|
Prior treatment
Platinum+/-Pemetrexed+/-Other
|
13 Participants
n=73 Participants
|
17 Participants
n=71 Participants
|
30 Participants
n=144 Participants
|
|
Prior treatment
Cisplatin/Pemetrexed and Carboplatin/Pemetrexed
|
7 Participants
n=73 Participants
|
1 Participants
n=71 Participants
|
8 Participants
n=144 Participants
|
|
Prior treatment
Missing
|
2 Participants
n=73 Participants
|
4 Participants
n=71 Participants
|
6 Participants
n=144 Participants
|
|
PD-L1 Tumour proportion score
<1%
|
36 Participants
n=73 Participants
|
30 Participants
n=71 Participants
|
66 Participants
n=144 Participants
|
|
PD-L1 Tumour proportion score
1-20%
|
20 Participants
n=73 Participants
|
18 Participants
n=71 Participants
|
38 Participants
n=144 Participants
|
|
PD-L1 Tumour proportion score
Not evaluable
|
2 Participants
n=73 Participants
|
4 Participants
n=71 Participants
|
6 Participants
n=144 Participants
|
|
PD-L1 Tumour proportion score
Not scored
|
4 Participants
n=73 Participants
|
5 Participants
n=71 Participants
|
9 Participants
n=144 Participants
|
PRIMARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).Population: All efficacy evaluations were conducted in the intent-to-treat (ITT) population.
To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test.
Outcome measures
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by Independent Radiological Review
|
2.5 months
Interval 2.1 to 4.2
|
3.4 months
Interval 2.2 to 4.3
|
SECONDARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).Defined as the best overall response (complete or partial response) across all assessment time-points from randomisation to end of trial treatment, determined by RECIST 1.1 criteria.
Outcome measures
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Objective Response Rate by Independent Radiological Review
|
21.9 percentage of participants
Interval 13.1 to 33.1
|
5.6 percentage of participants
Interval 1.6 to 13.8
|
SECONDARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date.
Outcome measures
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Overall Survival.
|
10.7 months
Interval 7.6 to 15.0
|
12.4 months
Interval 7.4 to 16.1
|
SECONDARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).Time from from randomisation to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, refusal and death, by Kaplan Meier method. Censoring will occur at the last follow-up date.
Outcome measures
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Time to Treatment Failure.
|
2.8 months
Interval 2.1 to 4.2
|
2.3 months
Interval 2.1 to 3.9
|
SECONDARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).Population: Safety evaluation was conducted in the as-treated (AT) population: all randomised patients that received at least one dose of trial treatment, with treatment assignments designed according to actual study treatment received.
The safety and tolerability of pembrolizumab treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment.
Outcome measures
| Measure |
Pembrolizumab Arm
n=72 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=70 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Percentage of Patients Experienced AEs/SAEs
Experienced any adverse event
|
70 Participants
|
65 Participants
|
|
Percentage of Patients Experienced AEs/SAEs
Experienced treatment related adverse event
|
50 Participants
|
52 Participants
|
|
Percentage of Patients Experienced AEs/SAEs
Experienced treatment related adverse event of grade 3-5
|
14 Participants
|
18 Participants
|
|
Percentage of Patients Experienced AEs/SAEs
Experienced treatment related adverse event leading to death
|
1 Participants
|
1 Participants
|
|
Percentage of Patients Experienced AEs/SAEs
Experienced treatment related adverse event leading to treatment discontinuation
|
5 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).Investigator assessed PFS, from the date of randomisation until documented progression or death, if progression is not documented. Censoring occurs at the last tumor assessment.
Outcome measures
| Measure |
Pembrolizumab Arm
n=73 Participants
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=71 Participants
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Progression Free Survival (PFS) Assessed by Investigator
|
3.5 months
Interval 2.1 to 4.2
|
3.7 months
Interval 2.2 to 4.3
|
Adverse Events
Pembrolizumab Arm
Serious events: 25 serious events
Other events: 70 other events
Deaths: 48 deaths
Standard Chemotherapy Arm
Serious events: 20 serious events
Other events: 65 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Pembrolizumab Arm
n=72 participants at risk
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=70 participants at risk
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
Infections and infestations
Lung infection
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
11.4%
8/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
7.1%
5/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Bronchial infection
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Pain
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Urinary tract infection
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Colitis
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Renal and urinary disorders
Acute kidney injury
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Endocrine disorders
Adrenal insufficiency
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Catheter related infection
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Psychiatric disorders
Confusion
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Immune system disorders
Cytokine release syndrome
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Cardiac disorders
Heart failure
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Malaise
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Otitis media
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Immune system disorders
Hypophysitis
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Infection NOS
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Lower respiratory infection
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Non-neutropaenic infection
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
Alkaline phosphatase increased
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Nervous system disorders
Syncope
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
Other adverse events
| Measure |
Pembrolizumab Arm
n=72 participants at risk
Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.
Pembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
|
Standard Chemotherapy Arm
n=70 participants at risk
Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.
Patients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.
Gemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the "faulty" nucleoside, resulting in apoptosis (cellular "suicide").
Vinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
|
|---|---|---|
|
General disorders
Fatigue
|
38.9%
28/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
45.7%
32/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
27.8%
20/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
14.3%
10/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Pain
|
26.4%
19/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
27.1%
19/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Constipation
|
23.6%
17/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
32.9%
23/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Nausea
|
22.2%
16/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
34.3%
24/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
16/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
37.1%
26/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
12/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
30.0%
21/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
16/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
4.3%
3/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.3%
11/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Vomiting
|
13.9%
10/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
11.4%
8/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.3%
11/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
4.3%
3/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.9%
10/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
4.3%
3/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Psychiatric disorders
Insomnia
|
11.1%
8/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
7.1%
5/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Lung infection
|
8.3%
6/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.7%
7/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Edema limbs
|
8.3%
6/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Mucositis oral
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
12.9%
9/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Urinary tract infection
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
4.3%
3/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Infections and infestations
Bronchial infection
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Flu like symptoms
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
GGT increased
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
1.4%
1/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
0.00%
0/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
Weight loss
|
6.9%
5/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
4.3%
3/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
3/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Nervous system disorders
Headache
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
8.6%
6/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Blood and lymphatic system disorders
Anemia
|
4.2%
3/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
15.7%
11/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
14.3%
10/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
11.4%
8/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
General disorders
Fever
|
2.8%
2/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
7.1%
5/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
0.00%
0/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Psychiatric disorders
Depression
|
4.2%
3/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Nervous system disorders
Paresthesia
|
1.4%
1/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
5.7%
4/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
|
Gastrointestinal disorders
Oral thrush
|
5.6%
4/72 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
2.9%
2/70 • Adverse events were assessed from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years). All-Cause Mortality was assessed from the date of randomization up to 2 years. All-Cause Mortality was assessed from the date of randomization until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).
In the 'All Cause Mortality' section, number of at risk patients includes all randomized patients, while in the 'Serious Adverse Events' and 'Other (Not Including Serious) Adverse Events' sections, at risk patients refer to the population who received at least one dose of trial treatment (safety cohort).
|
Additional Information
Heidi Roschitzki
European Thoracic Oncology Platform (ETOP)
Phone: +41 31 511 94 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place