Trial Outcomes & Findings for QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA (NCT NCT01147965)
NCT ID: NCT01147965
Last Updated: 2025-11-25
Results Overview
The primary objective of this protocol is to determine the safety of immunization with Ad5 \[E1-, E2b-\]-CEA(6D) in patients with advanced or metastatic CEA-expressing malignancies. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Every 3 weeks for 9 weeks and every 3 months for 1 year
Results posted on
2025-11-25
Participant Flow
Endpoints were tabulated as planned for the 43 patients by cohorts.
Participant milestones
| Measure |
Cohort 1
1x10\^9 VP (0.5 mL)
|
Cohort 2
1x10\^10 VP (0.5 mL)
|
Cohort 3
1x10\^11 VP (0.5 mL)
|
Cohort 4
Cohort 4 (Phase II): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
5x10\^11 VP (2.5 mL)
|
Cohort 6
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
7
|
14
|
6
|
9
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
7
|
14
|
6
|
8
|
Reasons for withdrawal
| Measure |
Cohort 1
1x10\^9 VP (0.5 mL)
|
Cohort 2
1x10\^10 VP (0.5 mL)
|
Cohort 3
1x10\^11 VP (0.5 mL)
|
Cohort 4
Cohort 4 (Phase II): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
5x10\^11 VP (2.5 mL)
|
Cohort 6
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Overall Study
Progressive Disease
|
3
|
3
|
5
|
9
|
5
|
5
|
|
Overall Study
Death
|
0
|
0
|
1
|
1
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Administration Of Alternative Therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
3
|
1
|
0
|
Baseline Characteristics
QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 7.21 • n=45 Participants
|
52.8 years
STANDARD_DEVIATION 7.80 • n=12929 Participants
|
54.0 years
STANDARD_DEVIATION 4.80 • n=6349 Participants
|
61.7 years
STANDARD_DEVIATION 8.31 • n=4548 Participants
|
55.5 years
STANDARD_DEVIATION 11.86 • n=28448 Participants
|
62.1 years
STANDARD_DEVIATION 7.46 • n=10 Participants
|
58.8 years
STANDARD_DEVIATION 8.56 • n=1353 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
3 Participants
n=6349 Participants
|
5 Participants
n=4548 Participants
|
3 Participants
n=28448 Participants
|
7 Participants
n=10 Participants
|
20 Participants
n=1353 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=45 Participants
|
3 Participants
n=12929 Participants
|
4 Participants
n=6349 Participants
|
9 Participants
n=4548 Participants
|
3 Participants
n=28448 Participants
|
2 Participants
n=10 Participants
|
23 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
2 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
1 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
7 Participants
n=6349 Participants
|
11 Participants
n=4548 Participants
|
6 Participants
n=28448 Participants
|
9 Participants
n=10 Participants
|
40 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=1353 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
0 Participants
n=4548 Participants
|
0 Participants
n=28448 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=1353 Participants
|
|
Subjects with advanced or metastatic malignancies expressing CEA
|
3 Participants
n=45 Participants
|
4 Participants
n=12929 Participants
|
7 Participants
n=6349 Participants
|
14 Participants
n=4548 Participants
|
6 Participants
n=28448 Participants
|
9 Participants
n=10 Participants
|
43 Participants
n=1353 Participants
|
PRIMARY outcome
Timeframe: Every 3 weeks for 9 weeks and every 3 months for 1 yearPopulation: Safety population
The primary objective of this protocol is to determine the safety of immunization with Ad5 \[E1-, E2b-\]-CEA(6D) in patients with advanced or metastatic CEA-expressing malignancies. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients).
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: from the time of first dose to the 30 days past last dose of study drug, up to 330 daysOutcome measures
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
2 Participants
|
3 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: from first dose up to a year follow upPopulation: Safety Population
Clinical response was assessed for participants that achieve a clinical response of complete response (CR) or partial response (PR), according to RECISIT criteria (v1.0 for Cohorts 1-5 and v1.1 for Cohort 6). CR is defined as disappearance of all target lesions. PR is defined as \>=30% decrease in the sum of the longest diameter of target lesions.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Clinical Response Rate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Week 0) up to Week 9Cell mediated immune response was characterized using ELISpot assays performed on Peripheral Blood Mononuclear Cells to determine the number of IFN-gamma secreting cells.
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Baseline
|
1.0 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 1.73
|
8.5 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 7.59
|
183.8 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 448.83
|
32.8 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 68.42
|
19.2 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 32.88
|
29.5 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 44.96
|
|
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Week 3
|
6.7 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 5.77
|
26.3 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 43.04
|
270.4 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 585.78
|
100.2 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 154.91
|
181.3 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 226.02
|
9.0 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 18.73
|
|
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Week 6
|
16.0 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 23.52
|
1.7 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 2.89
|
242.7 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 449.40
|
78.7 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 110.54
|
214.4 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 191.11
|
27.6 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 64.34
|
|
Immune Response Against CEA - IFN-gamma Secreting Cells by Visit
Week 9
|
0.0 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 0.00
|
13.3 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 23.09
|
59.0 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 98.77
|
188.4 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 364.15
|
82.4 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 93.84
|
10.3 Spot-forming cells per 1,000,000 PBMC
Standard Deviation 13.29
|
SECONDARY outcome
Timeframe: Baseline (Week 0) to Week 9Population: Safety Population
Summary of CEA Antibody (ng/mL) by Visit
Outcome measures
| Measure |
Cohort 1
n=3 Participants
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 Participants
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 Participants
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 Participants
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 Participants
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 Participants
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
CEA Antibody (ng/mL) by Visit
Week 9
|
0.0760 ng/mL
Standard Deviation 0.11953
|
0.0307 ng/mL
Standard Deviation 0.01106
|
0.1157 ng/mL
Standard Deviation 0.10571
|
0.0439 ng/mL
Standard Deviation 0.05536
|
0.3665 ng/mL
Standard Deviation 0.19723
|
0 ng/mL
Standard Deviation 0
|
|
CEA Antibody (ng/mL) by Visit
Baseline
|
0.0470 ng/mL
Standard Deviation 0.02291
|
0.0310 ng/mL
Standard Deviation 0.00400
|
0.0690 ng/mL
Standard Deviation 0.09319
|
0.0709 ng/mL
Standard Deviation 0.09117
|
0.3193 ng/mL
Standard Deviation 0.21676
|
0 ng/mL
Standard Deviation 0
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 3 deaths
Cohort 2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 3
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Cohort 4
Serious events: 1 serious events
Other events: 10 other events
Deaths: 8 deaths
Cohort 5
Serious events: 1 serious events
Other events: 6 other events
Deaths: 4 deaths
Cohort 6
Serious events: 2 serious events
Other events: 9 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 participants at risk
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 participants at risk
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 participants at risk
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 participants at risk
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 participants at risk
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Asthenia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
1x10\^9 VP (0.5 mL)
|
Cohort 2
n=4 participants at risk
1x10\^10 VP (0.5 mL)
|
Cohort 3
n=7 participants at risk
1x10\^11 VP (0.5 mL)
|
Cohort 4
n=14 participants at risk
(Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles
|
Cohort 5
n=6 participants at risk
5x10\^11 VP (2.5 mL)
|
Cohort 6
n=9 participants at risk
5x10\^11 VP (1.0 mL)
|
|---|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
66.7%
4/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Injection site reaction
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
50.0%
2/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
66.7%
4/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Fatigue
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
50.0%
3/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
44.4%
4/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
50.0%
3/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Chills
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
33.3%
2/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Pain
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
33.3%
2/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Injection site pain
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Oedema
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
33.3%
2/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Asthenia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Swelling
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Injection site erythema
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Injection site induration
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
General disorders
Malaise
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Abdominal wall haemorrhage
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
33.3%
3/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Biopsy skin
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Body temperature
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Menstruation normal
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Protein total decreased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
Weight decreased
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Investigations
White blood cell count
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
2/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
22.2%
2/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Chest wall mass
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
28.6%
2/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Skin and subcutaneous tissue disorders
Granuloma annulare
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
16.7%
1/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Eye disorders
Eyelid rash
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Eye disorders
Swelling of eyelid
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
25.0%
1/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
7.1%
1/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
11.1%
1/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/3 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/4 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
14.3%
1/7 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/14 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/6 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
0.00%
0/9 • AE monitoring occurred from the time of informed consent to 30 days after the last dose of study drug, up to 330 days.
Toxicity was graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Confidentiality Agreement in place.
- Publication restrictions are in place
Restriction type: OTHER