Trial Outcomes & Findings for Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations (NCT NCT02795156)

NCT ID: NCT02795156

Last Updated: 2023-12-05

Results Overview

ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

100 participants

Primary outcome timeframe

every 8 weeks until tumor progression or treatment discontinuation, up to 45 months.

Results posted on

2023-12-05

Participant Flow

Participant milestones

Participant milestones
Measure
Arm 1
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally once daily for each 28-day cycle regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 2
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 3
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 4
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally once daily for each 28-day cycle regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Overall Study
STARTED
39
10
42
9
Overall Study
COMPLETED
0
0
0
0
Overall Study
NOT COMPLETED
39
10
42
9

Reasons for withdrawal

Reasons for withdrawal
Measure
Arm 1
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally once daily for each 28-day cycle regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 2
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 3
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 4
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally once daily for each 28-day cycle regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Overall Study
Progressive Disease
22
7
34
7
Overall Study
Adverse Event
13
2
3
2
Overall Study
Death
1
1
1
0
Overall Study
Physician Decision
1
0
1
0
Overall Study
Withdrawal by Subject
2
0
3
0

Baseline Characteristics

Study Assessing Activity of Molecularly Matched Targeted Therapies in Select Tumor Types Based on Genomic Alterations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm 1
n=39 Participants
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally (p.o.) once daily for each 28-day cycle regorafenib: 160 mg p.o. once daily for the first 21-days of each 28-day Cabozantinib: 60 mg p.o. once daily for each 28-day cycle
Arm 2
n=10 Participants
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally (p.o.) once daily for each 28-day cycle regorafenib: 160 mg p.o. once daily for the first 21-days of each 28-day Cabozantinib: 60 mg p.o. once daily for each 28-day cycle
Arm 3
n=42 Participants
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally (p.o.) once daily for each 28-day cycle regorafenib: 160 mg p.o. once daily for the first 21-days of each 28-day Cabozantinib: 60 mg p.o. once daily for each 28-day cycle
Arm 4
n=9 Participants
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. afatinib: 40 mg orally (p.o.) once daily for each 28-day cycle regorafenib: 160 mg p.o. once daily for the first 21-days of each 28-day Cabozantinib: 60 mg p.o. once daily for each 28-day cycle
Total
n=100 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=93 Participants
2 Participants
n=4 Participants
12 Participants
n=27 Participants
5 Participants
n=483 Participants
28 Participants
n=36 Participants
Age, Categorical
>=65 years
30 Participants
n=93 Participants
8 Participants
n=4 Participants
30 Participants
n=27 Participants
4 Participants
n=483 Participants
72 Participants
n=36 Participants
Sex: Female, Male
Female
25 Participants
n=93 Participants
3 Participants
n=4 Participants
13 Participants
n=27 Participants
1 Participants
n=483 Participants
42 Participants
n=36 Participants
Sex: Female, Male
Male
14 Participants
n=93 Participants
7 Participants
n=4 Participants
29 Participants
n=27 Participants
8 Participants
n=483 Participants
58 Participants
n=36 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
0 Participants
n=4 Participants
3 Participants
n=27 Participants
0 Participants
n=483 Participants
5 Participants
n=36 Participants
Race (NIH/OMB)
White
35 Participants
n=93 Participants
10 Participants
n=4 Participants
39 Participants
n=27 Participants
9 Participants
n=483 Participants
93 Participants
n=36 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
2 Participants
n=36 Participants
Region of Enrollment
United States
39 Participants
n=93 Participants
10 Participants
n=4 Participants
42 Participants
n=27 Participants
9 Participants
n=483 Participants
100 Participants
n=36 Participants

PRIMARY outcome

Timeframe: every 8 weeks until tumor progression or treatment discontinuation, up to 45 months.

Population: All enrolled patients are included.

ORR is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR), i.e., two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target and non-target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure
Arm 1
n=39 Participants
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 2
n=10 Participants
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 3
n=42 Participants
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 4
n=9 Participants
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Overall Response Rate (ORR) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations
10.3 percentage of participants
Interval 2.87 to 24.22
0 percentage of participants
No participants in this arm met the definition of Overall Response Rate. Confidence interval can't be calculated.
7.1 percentage of participants
Interval 1.5 to 19.48
0 percentage of participants
No participants in this arm met the definition of Overall Response Rate. Confidence interval can't be calculated.

SECONDARY outcome

Timeframe: Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months

Population: All enrolled participants are included.

Clinical Benefit Rate (CBR) is defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR) or stable disease (SD) ≥ 6 months according to RECIST v1.1. Confirmed response is defined as two CRs and/or PRs at least 4 weeks apart, according to the RECIST v1.1 criteria. CR=disappearance of all target lesions. PR=at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Stable Disease= Neither sufficient shrinkage to qualify for PR nor sufficient increase of 20% in the sum of diameters or presence of a new lesion to qualify for progressive disease (PD), taking as reference the smallest (nadir) sum of diameters since the treatment started.

Outcome measures

Outcome measures
Measure
Arm 1
n=39 Participants
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 2
n=10 Participants
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 3
n=42 Participants
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 4
n=9 Participants
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Clinical Benefit Rate in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations
15.4 percentage of participants
Interval 5.86 to 30.5
0 percentage of participants
No participants met the definition of Clinical Benefit Rate. There is no confidence interval to be calculated.
21.4 percentage of participants
Interval 10.3 to 36.8
11.1 percentage of participants
Interval 0.28 to 48.2

SECONDARY outcome

Timeframe: Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months

Population: All enrolled participants were included.

Time to treatment failure is measured from the first day of treatment until the patient is removed from study for toxicity, disease progression per RECIST v1.1, patient choice, or death. Progressive disease (PD) per RECIST v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over the sum.

Outcome measures

Outcome measures
Measure
Arm 1
n=39 Participants
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 2
n=10 Participants
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 3
n=42 Participants
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 4
n=9 Participants
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Time to Treatment Failure (TTF) in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations
2.1 months
Interval 1.6 to 2.8
1.8 months
Interval 1.1 to 1.9
1.9 months
Interval 1.8 to 3.5
2.0 months
Interval 1.0 to 4.3

SECONDARY outcome

Timeframe: Every 8 weeks until tumor progression or treatment discontinuation, up to 45 months

Population: All enrolled participants were included.

Progression Free Survival (PFS) is defined as the time from the first day of study drug administration (Day 1) to disease progression as defined by the RECIST v1.1, or death on study. Patients who are alive and free from disease progression will be censored at the date of last tumor assessment. Progressive disease (PD) per RECIST v1.1 is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over the sum.

Outcome measures

Outcome measures
Measure
Arm 1
n=39 Participants
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 2
n=10 Participants
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 3
n=42 Participants
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Arm 4
n=9 Participants
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Regorafenib: 160 mg orally once daily for the first 21 days of each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months. Cabozantinib: 60 mg orally once daily for each 28-day cycle. Treatment will continue until disease progression or intolerable toxicity or other reason for discontinuation up to 45 months.
Progression-Free Survival in Each Arm Receiving Targeted Therapy Based on Relevant Genomic Alterations
3.2 months
Interval 2.7 to 4.4
1.9 months
Interval 1.5 to 3.3
3.1 months
Interval 2.3 to 4.2
2.8 months
Interval 1.8 to 8.6

Adverse Events

Arm 1

Serious events: 16 serious events
Other events: 39 other events
Deaths: 14 deaths

Arm 2

Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths

Arm 3

Serious events: 14 serious events
Other events: 41 other events
Deaths: 13 deaths

Arm 4

Serious events: 5 serious events
Other events: 8 other events
Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure
Arm 1
n=39 participants at risk
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 2
n=10 participants at risk
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 3
n=42 participants at risk
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 4
n=9 participants at risk
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Gastrointestinal disorders
Ileus
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal pain
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Diarrhoea
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Intestinal perforation
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Oesophageal stenosis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Pneumoperitoneum
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Small intestinal haemorrhage
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Vomiting
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Pneumonia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Sepsis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
COVID-19 pneumonia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Pneumonia klebsiella
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Urinary tract infection
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Wound infection
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Asthenia
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Pyrexia
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Fatigue
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Cerebrovascular accident
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Dizziness
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Nervous system disorder
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Syncope
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Cardiac arrest
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Cardiac failure congestive
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Cardiac tamponade
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Myocardial infarction
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood bilirubin increased
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood creatinine increased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
International normalised ratio increased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Dehydration
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hypovolaemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Hepatic failure
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Fall
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Confusional state
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Hypotension
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Other adverse events

Other adverse events
Measure
Arm 1
n=39 participants at risk
Patients with non-small cell lung cancer who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 2
n=10 participants at risk
Patients with urothelial carcinoma who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 3
n=42 participants at risk
Patients with non-colon gastrointestinal cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Arm 4
n=9 participants at risk
Patients with upper aerodigestive tract cancers who have failed first line treatment may receive either regorafenib (Stivarga), afatinib (Gilotrif), or cabozantinib (Cabometyx) at the recommended dose level, depending on their specific genomic alterations. Afatinib: 40 mg orally once daily for each 28-day cycle Regorafenib: 160 mg orally once daily for the first 21-days of each 28-day Cabozantinib: 60 mg orally once daily for each 28-day cycle
Gastrointestinal disorders
Diarrhoea
43.6%
17/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
100.0%
10/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
52.4%
22/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
33.3%
3/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Nausea
51.3%
20/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
70.0%
7/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
42.9%
18/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Vomiting
28.2%
11/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
50.0%
5/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
23.8%
10/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Constipation
23.1%
9/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
19.0%
8/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
33.3%
3/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Stomatitis
23.1%
9/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
21.4%
9/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
22.2%
2/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal pain
17.9%
7/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
14.3%
6/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal distension
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Dry mouth
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gastrooesophageal reflux disease
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Dyspepsia
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Dysphagia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Oral pain
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Retching
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal pain lower
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Anorectal discomfort
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Ascites
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Dental caries
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Flatulence
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Faeces discoloured
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Faeces pale
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gastritis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gingival pain
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Gingival ulceration
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Glossitis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Large intestinal obstruction
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Obstruction gastric
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Oesophagitis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Rectal haemorrhage
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Decreased appetite
43.6%
17/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
40.5%
17/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
33.3%
3/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Dehydration
41.0%
16/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
80.0%
8/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
28.6%
12/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hypokalaemia
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hypomagnesaemia
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
22.2%
2/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hyperglycaemia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Failure to thrive
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hypocalcaemia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Alkalosis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Fatigue
48.7%
19/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
70.0%
7/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
47.6%
20/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
44.4%
4/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Mucosal inflammation
12.8%
5/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
40.0%
4/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Asthenia
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Oedema peripheral
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
22.2%
2/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Chills
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Pain
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Pyrexia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Gait disturbance
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Non-cardiac chest pain
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Chest pain
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
General disorders
Early satiety
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Weight decreased
30.8%
12/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
16.7%
7/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Aspartate aminotransferase increased
12.8%
5/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
14.3%
6/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood bilirubin increased
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
16.7%
7/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Alanine aminotransferase increased
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood alkaline phosphatase increased
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
16.7%
7/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Platelet count decreased
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood creatinine increased
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood albumin decreased
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Blood potassium decreased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Liver function test increased
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Alanine aminotransferase
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Amylase increased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Ejection fraction decreased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Lipase increased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Lymphocyte count decreased
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Investigations
Protein total increased
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash
15.4%
6/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
15.4%
6/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash maculo-papular
17.9%
7/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
22.2%
2/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Dry skin
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Pruritus
15.4%
6/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Erythema
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Skin exfoliation
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Palmar erythema
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash erythematous
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Skin ulcer
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Night sweats
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Skin disorder
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Papule
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash papular
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Rash pruritic
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Skin hypopigmentation
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
20.5%
8/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Dysphonia
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
16.7%
7/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Cough
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Epistaxis
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Back pain
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
19.0%
8/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Arthralgia
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Pain in extremity
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Muscular weakness
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Muscle spasms
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Arthropathy
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Joint swelling
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Limb mass
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Headache
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Dizziness
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Tremor
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Dysgeusia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Balance disorder
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Neuropathy peripheral
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Peripheral sensory neuropathy
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Amnesia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Anosmia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Aphasia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Burning sensation
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Cerebrovascular accident
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Dysarthria
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Encephalopathy
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Hepatic encephalopathy
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Lethargy
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Post herpetic neuralgia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Seizure
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Nervous system disorders
Somnolence
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Urinary tract infection
7.7%
3/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Rash pustular
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Sepsis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Bronchitis
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Diverticulitis
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Lower respiratory tract infection
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Sinusitis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Upper respiratory tract infection
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Bacteraemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Candida infection
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Catheter site cellulitis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Conjunctivitis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Eczema infected
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Escherichia bacteraemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Herpes zoster
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Infection
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Laryngitis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Mucosal infection
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Nail infection
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Paronychia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Pharyngitis streptococcal
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Pneumonia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Pneumonia bacterial
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Infections and infestations
Vulval abscess
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Anaemia
12.8%
5/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
22.2%
2/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Thrombocytopenia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
16.7%
7/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Iron deficiency anaemia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Lymphopenia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Insomnia
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Depression
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Anxiety
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Confusional state
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Psychiatric disorders
Delirium
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Hypotension
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
20.0%
2/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.9%
5/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Hypertension
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
9.5%
4/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Hot flush
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Deep vein thrombosis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Vascular disorders
Embolism
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Fall
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
7.1%
3/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Anal injury
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Contusion
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Foreign body
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Lip injury
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Skin abrasion
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Sunburn
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Injury, poisoning and procedural complications
Tracheal haemorrhage
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
11.1%
1/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Dysuria
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Acute kidney injury
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Pollakiuria
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Urinary retention
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Micturition urgency
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Tachycardia
10.3%
4/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Atrial fibrillation
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
10.0%
1/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Sinus tachycardia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders
Eye pruritus
5.1%
2/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders
Vision blurred
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
4.8%
2/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders
Blindness
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders
Lacrimation increased
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Eye disorders
Retinopathy
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Jaundice
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Biliary obstruction
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Cholecystitis
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Hepatobiliary disorders
Hypertransaminasaemia
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Surgical and medical procedures
Cholecystectomy
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Surgical and medical procedures
Stent placement
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Surgical and medical procedures
Tooth extraction
2.6%
1/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Ear and labyrinth disorders
Ear pain
0.00%
0/39 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/10 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
2.4%
1/42 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
0.00%
0/9 • Serious and/or other adverse events were assessed from the date of first dose to 30 days after last dose of study treatment, up to 45 months. All-Cause Mortality was monitored from date of consent up until progression of disease or death, up to 45 months.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Additional Information

Sarah Cannon Development Innovations, LLC

Sarah Cannon Development Innovations, LLC

Phone: 844-710-6157

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60