Trial Outcomes & Findings for NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors (NCT NCT00299728)
NCT ID: NCT00299728
Last Updated: 2022-10-10
Results Overview
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0). DLT was defined as ≥ Grade 3 hematological and non-hematological toxicities or ≥ Grade 2 allergic reaction for generalized urticaria that was definitely, probably, or possibly related to the administration of the NY-ESO-1 protein vaccine.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
up to 14 weeks
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Progressive disease
|
0
|
1
|
Baseline Characteristics
NY-ESO-1 Protein With Montanide and CpG 7909 as Cancer Vaccine in Several Tumors
Baseline characteristics by cohort
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 15.5 • n=5 Participants
|
56 years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
54.1 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 14 weeksPopulation: All subjects who entered the study and received the NY-ESO-1 protein vaccine.
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0). DLT was defined as ≥ Grade 3 hematological and non-hematological toxicities or ≥ Grade 2 allergic reaction for generalized urticaria that was definitely, probably, or possibly related to the administration of the NY-ESO-1 protein vaccine.
Outcome measures
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs)
Number of subjects reporting AEs
|
11 Participants
|
11 Participants
|
|
Number of Subjects Reporting Adverse Events (AEs) and Dose-limiting Toxicities (DLTs)
Number of subjects with DLTs
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 14 weeksPopulation: All subjects who entered the study and received the NY-ESO-1 protein vaccine and had antibody titers measured both pre-and post-treatment.
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, and 12-14 for the assessment of NY-ESO-1-specific antibodies by an enzyme-linked immunosorbent assay (ELISA). Sera were assessed over a range of dilutions from 1/100 to 1/100,000. Titers were calculated as the serum dilution giving 50% of maximal optical density obtained by using a standard positive serum. Positive results were reciprocal serum titers greater than 100.
Outcome measures
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=7 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Number of Subjects With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Number of subjects with positive antibody titers at baseline and after treatment
|
1 Participants
|
0 Participants
|
|
Number of Subjects With NY-ESO-1-Specific Humoral Immunity as Determined by an Increase in Antibody Titer From Baseline.
Number of subjects with negative titers at baseline and positive titers following treatment
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 18 weeksPopulation: All subjects who entered the study and received the NY-ESO-1 protein vaccine and had at least one post-treatment tumor assessment.
Computed tomography (CT) or magnetic resonance imaging (MRI) scans were performed at screening and weeks 12-14 and 16-18, and tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) according to Therasse P et al. 2000. Per RECIST, target lesions were categorized as follows: complete response (CR): disappearance of all target lesions; partial response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; progressive disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; stable disease (SD): small changes that do not meet above criteria; no evidence of disease (NED): no evidence of disease at baseline and post-baseline assessments.
Outcome measures
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=10 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
CR
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
PR
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
SD
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
PD
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Tumor Responses as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST)
NED
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 32 weeksPopulation: All subjects who entered the study, received the NY-ESO-1 protein vaccine and had pre- and post-treatment samples analyzed for NY-ESO-1 Specific CD4+ T cells.
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, 12-14, 16-18, 20-22, 24-26, and 28-32. Subjects were consented separately for blood draws after week 14. The induction of specific T cells was assessed after in vitro stimulation of pre- and post-treatment samples with a pool of overlapping peptides spanning the protein sequence, followed by quantification of specific IFN-γ-producing cells by intracellular staining. The response was considered significant if the frequency of T cells detected in at least one post-treatment sample exceeded by 3-fold that found in the baseline sample.
Outcome measures
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=7 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Number of Subjects With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ T Cells After in Vitro Stimulation
Number of subjects with an increase of NY-ESO-1 Specific CD4+ T cells after treatment
|
10 Participants
|
7 Participants
|
|
Number of Subjects With NY-ESO-1 Specific Cellular Immunity as Measured by an Increase in NY-ESO-1-Specific CD4+ T Cells After in Vitro Stimulation
Number of subjects without an increase of NY-ESO-1 Specific CD4+ T cells after treatment
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 32 weeksPopulation: All subjects who entered the study, received the NY-ESO-1 protein vaccine and had pre- and post-treatment samples analyzed for NY-ESO-1-Specific CD8+ T cells.
Blood samples were taken at baseline and in weeks 2, 4, 5, 7, 8, 10, 11, 12-14, 16-18, 20-22, 24-26, and 28-32. Subjects were consented separately for blood draws after week 14. The induction of specific T cells was assessed after in vitro stimulation of pre- and post-treatment samples with a pool of overlapping peptides spanning the protein sequence, followed by quantification of specific IFN-γ-producing cells by intracellular staining. The response was considered significant if the frequency of T cells detected in at least one post-treatment sample exceeded by 3-fold that found in the baseline sample.
Outcome measures
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 Participants
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=7 Participants
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
Number of Subjects With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO--Specific CD8+ T Cells After in Vitro Stimulation
Number of subjects with an increase of NY-ESO-1-Specific CD8+ T cells after treatment
|
5 Participants
|
4 Participants
|
|
Number of Subjects With NY-ESO-1-Specific Cellular Immunity as Measured by an Increase in NY-ESO--Specific CD8+ T Cells After in Vitro Stimulation
Number of subjects without an increase of NY-ESO-1-Specific CD8+ T cells after treatment
|
6 Participants
|
3 Participants
|
Adverse Events
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A; 100 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 participants at risk
100 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
Arm B; 400 μg NY-ESO-1 Protein Co-mixed With CpG 7909 and Montanide ISA-51 VG
n=11 participants at risk
400 μg NY-ESO-1 protein co-mixed with 2.5 mg CpG 7909 and 1.25 mL Montanide ISA-51 VG. The vaccine was administered subcutaneously every 3 weeks for a total of 4 doses (study weeks 1, 4, 7 and 10).
|
|---|---|---|
|
General disorders
Injection site induration
|
100.0%
11/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
81.8%
9/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site erythema
|
72.7%
8/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
72.7%
8/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site discomfort
|
63.6%
7/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
54.5%
6/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site pain
|
45.5%
5/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
72.7%
8/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Fatigue
|
54.5%
6/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
54.5%
6/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site nodule
|
54.5%
6/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
45.5%
5/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site pruritus
|
27.3%
3/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
27.3%
3/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site reaction
|
27.3%
3/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Pyrexia
|
63.6%
7/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
45.5%
5/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
3/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
45.5%
5/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
36.4%
4/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Headache
|
54.5%
6/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Edema peripheral
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Investigations
Body temperature increased
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Chills
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Induration
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site haematoma
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site swelling
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Asthenia
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Gait disturbance
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site discoloration
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site injury
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
General disorders
Injection site rash
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Infections and infestations
Abscess
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Dysgeusia
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Migrane
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Renal and urinary disorders
Pollakiuria
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
18.2%
2/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
|
Vascular disorders
Hypotension
|
9.1%
1/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
0.00%
0/11 • up to 14 weeks
All AEs occurring during the study were documented in the source records and on the respective AE case report form (CRF) pages, regardless of the assumption of a causal relationship. All events that occurred after the first administration of study drug up to the end of week 14 were to be documented. The severity of an AE was assessed according to the NCI CTCAE scale (Version 3.0).
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place