Trial Outcomes & Findings for Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR) (NCT NCT01990209)
NCT ID: NCT01990209
Last Updated: 2022-06-30
Results Overview
Response rate (RR) will be estimated as the percentage of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete and partial responses were confirmed at least 4 weeks after the initial response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
upto 36 months
Results posted on
2022-06-30
Participant Flow
71 participants were enrolled
In this study, the first 6 participants enrolled in cohorts 1 and 2 were evaluated as part of a safety lead-in phase following pre-screening for AR expression. The lead-in did not affect the cohort assignments; the assignment was decided by Inclusion Criteria. After these 6 patients completed at least 4 weeks of treatment without any prohibitive toxicities, the study continued to enroll the rest of the study participants.
Participant milestones
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
44
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
27
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Orteronel as Monotherapy in Patients With Metastatic Breast Cancer (MBC) That Expresses the Androgen Receptor (AR)
Baseline characteristics by cohort
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=27 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 13.73 • n=93 Participants
|
63.1 years
STANDARD_DEVIATION 11.34 • n=4 Participants
|
61.1 years
STANDARD_DEVIATION 12.47 • n=27 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
43 Participants
n=4 Participants
|
66 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=93 Participants
|
39 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=93 Participants
|
44 participants
n=4 Participants
|
71 participants
n=27 Participants
|
|
Patients with Bone-only disease
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
HER2 positive patients
|
0 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: upto 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and was excluded from the analysis. Participants with bone-only metastases (4 in cohort 1 and 8 in cohort 2) were excluded from the analysis as they are not evaluable by RECIST V1.1. 14 participants, 1 in cohort 1 and 13 in cohort 2 who discontinued treatment prior to having a post-baseline scan were excluded. Participants who received at least one dose of study drug and with one post-baseline scan were included.
Response rate (RR) will be estimated as the percentage of patients exhibiting complete response or partial response out of all evaluable cases. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Complete and partial responses were confirmed at least 4 weeks after the initial response.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=21 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=23 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Response Rate (RR)
|
4.8 percentage of participants
Interval 0.1 to 23.82
|
0 percentage of participants
Interval 0.0 to 14.82
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and was excluded from the analysis. Participants with bone-only metastases (4 in cohort 1 and 8 in cohort 2) were excluded from the analysis as they are not evaluable by RECIST V1.1. 14 participants, 1 in cohort 1 and 13 in cohort 2 who discontinued treatment prior to having a post-baseline scan were excluded. Participants who received at least one dose of study drug and with one post-baseline scan were included.
Defined as the percentage of patients who do not exhibit progression (CR+PR+SD) at 6 months among those patients who are evaluable for response by RECIST V1.1. Complete Response is defined per RECIST as the disappearance of all target/non-target lesions and normalization of tumor markers. Partial Response is defined per RECIST as At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease is defined per RECIST as Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest (nadir) sum LD since the treatment started.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=21 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=23 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
4.8 percentage of participants
Interval 0.1 to 23.8
|
8.7 percentage of participants
Interval 1.1 to 28.0
|
SECONDARY outcome
Timeframe: weekly for 4 weeks then every 8 weeks until end of study treatment, up to 36 months.Population: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis.
Assessments will be made through analysis of the reported incidence of treatment-related Adverse Events as determined by the investigator and assessed by NCI CTCAE, Version 4.0.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events as a Measure of Safety
|
20 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Every 8 weeks during treatment then every 6 months for 2 years, annually thereafter up to 5 years.Population: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis.
Progression-free survival is defined as the time from the first day of treatment until the day tumor progression or date of death was documented. The response was evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
2 months
Interval 1.2 to 5.2
|
1.8 months
Interval 1.7 to 3.6
|
SECONDARY outcome
Timeframe: After disease progression is documented, survival was monitored every 6 months for 2 years and annually thereafter up to 5 years.Population: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis.
OS is defined as the time from the first treatment until the date of death due to any cause. In the absence of confirmation of death or lack of data beyond the follow-up period, the survival time was censored to the last date the participant was known to be alive.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Overall Survival (OS)
|
10.2 months
Interval 4.3 to
The upper limit was not reached by the Kaplan-Meier method during the follow-up period due to an insufficient number of participants with events
|
7.6 months
Interval 3.9 to 9.7
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported.
Blood samples collected At baseline, at day 1 of cycle 2 and 4, and at end of treatment visit to test for serum estradiol levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Estradiol
Cycle 2 Day 1
|
22.29 pg/ml
Interval 0.0 to 91.0
|
26.99 pg/ml
Interval 7.6 to 143.0
|
|
Measurement of Serum Hormone Levels - Estradiol
Cycle 4 Day 1
|
20.86 pg/ml
Interval 0.0 to 70.0
|
33 pg/ml
Interval 5.0 to 124.0
|
|
Measurement of Serum Hormone Levels - Estradiol
End of Treatment
|
25.46 pg/ml
Interval 5.0 to 144.0
|
28.15 pg/ml
Interval 5.0 to 87.0
|
|
Measurement of Serum Hormone Levels - Estradiol
Baseline
|
31.99 pg/ml
Interval 5.0 to 235.0
|
29.16 pg/ml
Interval 6.0 to 138.0
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of treatment visit to test total testosterone levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Total Testosterone
Baseline
|
16.36 ng/dL
Interval 0.0 to 65.0
|
24.79 ng/dL
Interval 2.0 to 404.0
|
|
Measurement of Serum Hormone Levels - Total Testosterone
Cycle 2 Day 1
|
4.23 ng/dL
Interval 0.0 to 11.0
|
4.35 ng/dL
Interval 1.0 to 23.0
|
|
Measurement of Serum Hormone Levels - Total Testosterone
Cycle 4 Day 1
|
3.71 ng/dL
Interval 1.0 to 8.0
|
2.4 ng/dL
Interval 1.0 to 4.0
|
|
Measurement of Serum Hormone Levels - Total Testosterone
End of Treatment
|
6.11 ng/dL
Interval 0.0 to 20.0
|
8.5 ng/dL
Interval 0.0 to 42.0
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported.
Blood samples were collected At baseline, at day 1 of cycle 2 and 4, and at end of treatment visit to test free testosterone levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Free Testosterone
Baseline
|
1.62 pg/mL
Interval 0.3 to 6.2
|
4.13 pg/mL
Interval 0.0 to 111.3
|
|
Measurement of Serum Hormone Levels - Free Testosterone
Cycle 2 Day 1
|
0.31 pg/mL
Interval 0.0 to 0.7
|
0.39 pg/mL
Interval 0.1 to 1.8
|
|
Measurement of Serum Hormone Levels - Free Testosterone
Cycle 4 Day 1
|
0.36 pg/mL
Interval 0.1 to 0.6
|
0.16 pg/mL
Interval 0.1 to 0.3
|
|
Measurement of Serum Hormone Levels - Free Testosterone
End of treatment
|
0.6 pg/mL
Interval 0.0 to 2.0
|
1.01 pg/mL
Interval 0.0 to 3.7
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit for sex hormone-binding globulin (SHBG) levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
Baseline
|
81.95 nmol/L
Interval 28.0 to 191.1
|
72.88 nmol/L
Interval 23.0 to 162.0
|
|
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
Cycle 2 Day 1
|
82.7 nmol/L
Interval 25.0 to 183.0
|
91.93 nmol/L
Interval 20.0 to 262.0
|
|
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
Cycle 4 Day 1
|
67.17 nmol/L
Interval 43.0 to 142.2
|
118.54 nmol/L
Interval 68.0 to 168.0
|
|
Measurement of Serum Hormone Levels - Sex Hormone-binding Globulin
End of Treatment
|
77.69 nmol/L
Interval 19.0 to 163.0
|
73.48 nmol/L
Interval 21.0 to 190.0
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit to test for adrenocorticotropic hormone (ACTH) levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
Baseline
|
16.86 pg/mL
Interval 4.9 to 41.0
|
18.61 pg/mL
Interval 4.0 to 71.0
|
|
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
Cycle 2 Day 1
|
62.82 pg/mL
Interval 4.3 to 189.0
|
58.04 pg/mL
Interval 5.0 to 255.0
|
|
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
Cycle 4 Day 1
|
56.55 pg/mL
Interval 10.44 to 104.9
|
214.94 pg/mL
Interval 8.0 to 845.0
|
|
Measurement of Serum Hormone Levels - Adrenocorticotropic Hormone
End of treatment
|
42.14 pg/mL
Interval 5.0 to 161.0
|
40.26 pg/mL
Interval 5.0 to 265.0
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported
Blood samples were collected at baseline, on day 1 of cycles 2 and 4, and at end of the treatment visit dehydroepiandrosterone sulfate (DHEA-S) levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
Baseline
|
74.63 µg/dL
Interval 9.0 to 199.0
|
54.8 µg/dL
Interval 9.0 to 146.0
|
|
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
Cycle 2 Day 1
|
16.54 µg/dL
Interval 2.0 to 43.0
|
14.48 µg/dL
Interval 2.0 to 82.0
|
|
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
cycle 4 Day 1
|
23.29 µg/dL
Interval 3.0 to 79.0
|
10.3 µg/dL
Interval 2.0 to 25.5
|
|
Measurement of Serum Hormone Levels - Dehydroepiandrosterone Sulfate (DHEA-S)
End of Treatment
|
36.85 µg/dL
Interval 1.0 to 168.0
|
34.31 µg/dL
Interval 2.0 to 158.0
|
SECONDARY outcome
Timeframe: At baseline, at day 1 of cycle 2 and 4 (treatment cycle repeated every 4 weeks), and at end of treatment visit, up to 36 monthsPopulation: One participant in cohort 1 was found to be ineligible after starting treatment and hence was excluded from the analysis. Available data from the samples collected at each timepoint is reported
Blood samples to test for serum cortisol levels
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Measurement of Serum Hormone Levels - Cortisol
cycle 4 Day 1
|
7.14 µg/dL
Interval 5.7 to 9.8
|
11 µg/dL
Interval 3.9 to 24.9
|
|
Measurement of Serum Hormone Levels - Cortisol
End of Treatment
|
8.16 µg/dL
Interval 1.5 to 13.6
|
12.34 µg/dL
Interval 1.7 to 42.7
|
|
Measurement of Serum Hormone Levels - Cortisol
Baseline
|
10.45 µg/dL
Interval 3.7 to 21.7
|
12.89 µg/dL
Interval 4.2 to 31.1
|
|
Measurement of Serum Hormone Levels - Cortisol
Cycle 2 Day 1
|
7.08 µg/dL
Interval 2.3 to 13.7
|
6.91 µg/dL
Interval 2.0 to 14.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At pre-screeningPopulation: Intent to treat analysis set. All enrolled participants' tissue was analyzed for loss of gene expression. Results are not reported for 6 participants in cohort 1, and 10 participants in cohort 2 who could not be assayed because of insufficient tissue available for testing or because their assay had indeterminate results.
Archived tumor tissue was assayed for loss of phosphatase and tensin homolog (PTEN) biomarker. PTEN loss was determined by immunohistochemistry (IHC) staining. pTEN Positive by IHC is defined as strongly positive (2+ intensity) staining for PTEN protein expression in the entire tumor or the vast majority of the tumor cells. pTEN Negative by IHC is defined as no staining (0+intensity) in entire tumor cells for pTEN protein expression. pTEN Weakly positive(1+intensity) by IHC is defined as tumor cells showing weak pTEN protein expression.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=20 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=34 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Number of Participants With PTEN Gene Expression Status of Positive, Weak Positive, or Negative
Positive
|
6 Participants
|
18 Participants
|
|
Number of Participants With PTEN Gene Expression Status of Positive, Weak Positive, or Negative
Weak Positive
|
1 Participants
|
7 Participants
|
|
Number of Participants With PTEN Gene Expression Status of Positive, Weak Positive, or Negative
Negative
|
13 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At pre-screeningPopulation: Intent to treat analysis set. All enrolled participants' tissue was analyzed for loss of gene expression. Results are not reported for 8 participants in cohort 1, and 11 participants in cohort 2 who could not be assayed because of insufficient tissue or because of their assay had indeterminate results.
Archived tumor tissue was assayed for the phosphatidylinositol 3-kinase (PIK3CA) biomarker. PIK3CA hotspot mutations at codons 88, 539-549, 1020-1025, 1043-1049 were tested by pyrosequencing. 'PIK3CA-'mutated' is defined as the presence of mutation in one of the codons 88, 539-549, 1020-1025, 1043-1049 of the PIK3CA gene. PIK3CA-'no mutation' is defined as the absence of mutation in codons 88, 539-549, 1020-1025, 1043-1049 of the PIK3CA gene.
Outcome measures
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=18 Participants
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/Androgen receptor-positive (AR +) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=33 Participants
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Number of Participants With PIK3CA Gene Mutation Status of Mutated or No Mutation
Mutated
|
3 Participants
|
12 Participants
|
|
Number of Participants With PIK3CA Gene Mutation Status of Mutated or No Mutation
No mutation
|
15 Participants
|
21 Participants
|
Adverse Events
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
Serious events: 11 serious events
Other events: 20 other events
Deaths: 23 deaths
Cohort 2: AR+/HR+/HER2 +/- Tumors
Serious events: 11 serious events
Other events: 38 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 participants at risk
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/AR-positive (+) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 participants at risk
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Endocrine disorders
Diabetes insipidus
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Chest pain
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Fatigue
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Non-cardiac chest pain
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Oedema peripheral
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Intracranial mass
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Transient ischaemic attack
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Suicide attempt
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Hypertension
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Superior vena cava syndrome
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
Other adverse events
| Measure |
Cohort 1: Patients With AR+/ER-/PR-/HER2- Tumors
n=26 participants at risk
Patients with estrogen receptor-negative (ER-)/progesterone receptor negative (PR-)/ human epidermal growth factor receptor 2 negative (HER2-)/AR-positive (+) MBC with 1 to 3 previous treatments for metastatic disease
|
Cohort 2: AR+/HR+/HER2 +/- Tumors
n=44 participants at risk
Postmenopausal women with hormone receptor (HR) positive (ER+ and/or PR+) /AR-positive (+) refractory MBC who have progressed after at least one and up to 3 previous hormonal treatments for metastatic disease.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.5%
3/26 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Cardiac disorders
Left ventricular hypertrophy
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Cardiac disorders
Palpitations
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Cardiac disorders
Sinus tachycardia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Eye disorders
Blepharitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Eye disorders
Eyelid margin crusting
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
3/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
11.4%
5/44 • Number of events 7 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
7/26 • Number of events 8 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
27.3%
12/44 • Number of events 14 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Dental paraesthesia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Diarrhoea
|
19.2%
5/26 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
15.9%
7/44 • Number of events 9 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Dysphagia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Lip exfoliation
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
14/26 • Number of events 15 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
43.2%
19/44 • Number of events 24 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Pancreatitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Stomatitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Gastrointestinal disorders
Vomiting
|
19.2%
5/26 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
22.7%
10/44 • Number of events 14 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Asthenia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Chest pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Chills
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Early satiety
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Facial pain
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Fatigue
|
50.0%
13/26 • Number of events 16 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
47.7%
21/44 • Number of events 34 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Gait disturbance
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Localised oedema
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Malaise
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Oedema peripheral
|
11.5%
3/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Pain
|
11.5%
3/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Peripheral swelling
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Pyrexia
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Swelling
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Tenderness
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
General disorders
Thirst
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Hepatobiliary disorders
Biliary dilatation
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Bronchitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Sinusitis
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Alanine aminotransferase increased
|
11.5%
3/26 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
11.4%
5/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Amylase
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Amylase increased
|
11.5%
3/26 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 7 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Aspartate aminotransferase increased
|
19.2%
5/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
13.6%
6/44 • Number of events 7 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood albumin decreased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood alkaline phosphatase increased
|
15.4%
4/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
11.4%
5/44 • Number of events 7 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood lactate dehydrogenase increased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Blood sodium decreased
|
3.8%
1/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Ejection fraction decreased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Haematocrit decreased
|
7.7%
2/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Haemoglobin
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Haemoglobin decreased
|
3.8%
1/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Lipase
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Lipase increased
|
7.7%
2/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
13.6%
6/44 • Number of events 11 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Neutrophil count
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Neutrophil count decreased
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Neutrophil count increased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Platelet count
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Platelet count decreased
|
7.7%
2/26 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Protein total increased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Transaminases increased
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
Weight decreased
|
11.5%
3/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
11.4%
5/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
White blood cell count
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Investigations
White blood cell count decreased
|
7.7%
2/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.2%
5/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
20.5%
9/44 • Number of events 11 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 8 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.4%
4/26 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
23.1%
6/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscle discomfort
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
11.4%
5/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Dizziness
|
7.7%
2/26 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Headache
|
23.1%
6/26 • Number of events 7 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
22.7%
10/44 • Number of events 13 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Hypoaesthesia
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Migraine
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Neuropathy peripheral
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Nervous system disorders
Tremor
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Depression
|
7.7%
2/26 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Hallucination
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Restlessness
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Psychiatric disorders
Suicidal ideation
|
3.8%
1/26 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Renal and urinary disorders
Proteinuria
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.2%
5/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
18.2%
8/44 • Number of events 8 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 3 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
0.00%
0/44 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.8%
1/26 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
6.8%
3/44 • Number of events 5 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Flushing
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Hot flush
|
23.1%
6/26 • Number of events 6 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
9.1%
4/44 • Number of events 4 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Hypertension
|
11.5%
3/26 • Number of events 8 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
13.6%
6/44 • Number of events 10 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Hypotension
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
4.5%
2/44 • Number of events 2 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/26 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
2.3%
1/44 • Number of events 1 • Up to 36 months for Serious Adverse Events and Other Adverse Events. Up to 5 years for All-Cause Mortality.
All patients who received at least one dose of protocol treatment were followed for safety. Adverse events and serious adverse events were collected from the day of the first dose to 30 days after the last dose of the study medication and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. One participant in cohort 1 was found to be ineligible after starting with study treatment and hence excluded from further analyses.
|
Additional Information
Sarah Cannon Development Innovations, LLC
Sarah Cannon Development Innovations, LLC
Phone: 844-710-6157
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60