Trial Outcomes & Findings for Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma (NCT NCT02659540)
NCT ID: NCT02659540
Last Updated: 2022-10-28
Results Overview
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 100 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Up to 25 months
Results posted on
2022-10-28
Participant Flow
Participant milestones
| Measure |
Cohort A (Conventional RT)
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
| Measure |
Cohort A (Conventional RT)
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Progressive disease
|
2
|
6
|
Baseline Characteristics
Pilot Study of the Safety/Efficacy of Combination Checkpoint Blockade + External Beam Radiotherapy in Stage IV Melanoma
Baseline characteristics by cohort
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
51 years
n=7 Participants
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 25 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) were reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent was signed through 100 days after the last dose of study treatment. Treatment-emergent AEs were those that occurred or worsened after administration of the first dose of study treatment.
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Any TEAE
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Treatment-related TEAE
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Serious TEAE
|
6 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The population comprises all subjects who received at least one dose of study treatment and had a Week 12 imaging assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per RECIST 1.1, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Number of Subjects With Tumor Response at Week 12 by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PR
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
SD
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
PD
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Not evaluated
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: The population comprises all subjects who received at least one dose of study treatment and had a Week 18 imaging assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to RECIST 1.1 at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per RECIST 1.1, target lesions are categorized as follows: CR: Disappearance of all target lesions; PR: ≥ 30% decrease in the sum of the longest diameter of target lesions; PD: ≥ 20% increase in the sum of the longest diameter of target lesions; SD: small changes that do not meet above criteria (Eisenhauer et al. Eur J Cancer 2009;45:228-47).
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Number of Subjects With Tumor Response at Week 18 by RECIST 1.1
PR
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by RECIST 1.1
SD
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by RECIST 1.1
PD
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by RECIST 1.1
Not evaluated
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The population comprises all subjects who received at least one dose of study treatment and had a Week 12 imaging assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the total measurable tumor burden (TMTB); irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria (Bohnsack et al. Ann Oncol 2014;25: iv361-iv72).
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Number of Subjects With Tumor Response at Week 12 by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPR
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irSD
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
irPD
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Tumor Response at Week 12 by Immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
Not evaluated
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 18 weeksPopulation: The population comprises all subjects who received at least one dose of study treatment and had a Week 18 imaging assessment.
Tumor responses were evaluated using appropriate imaging and categorized according to irRECIST at Screening (up to 28 days before the first dose of study treatment), at Weeks 12, 18, and 24, and every 12 weeks (± 7 days) thereafter until progression or start of alternate anticancer therapy. Per irRECIST, measurable lesions are categorized as follows: irCR: Complete disappearance of all target lesions; irPR: ≥ 30% decrease from baseline in the TMTB; irPD: ≥ 20% increase from nadir in TMTB; irSD: not meeting above criteria (Bohnsack et al. Ann Oncol 2014;25: iv361-iv72).
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Number of Subjects With Tumor Response at Week 18 by irRECIST
irPR
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by irRECIST
irSD
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by irRECIST
irPD
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Tumor Response at Week 18 by irRECIST
Not evaluated
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 years post-studyPopulation: Duration of response was not measured in this study
Duration of response will be determined for each subject with time origin at the first occurrence of response until the first occurrence of progression or date of death if the subject dies due to any causes before progression. Every effort will be made to follow subjects for progression after they discontinue the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 and 6 months after the start of treatmentPopulation: The population comprises all subjects who received at least one dose of study treatment.
Progression-free survival will be defined as the number of days from the date of first dose of study drug to the date of earliest disease progression or to the date of death, if disease progression does not occur. Subjects who do not progress and are still alive will be censored on the date of last follow-up or start of new treatment, whichever comes first. Living patients were censored at last off-study follow-up visit, last scan date, or at the end of study if no follow-up was available. PFS was estimated by Kaplan-Meier methodology.
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Percent of Patients With Progression-free Survival at 3 and 6 Months Post Start of Treatment
Progression-free Survival at 3 months
|
50 percent of participants
Interval 18.4 to 75.3
|
50 percent of participants
Interval 18.4 to 75.3
|
|
Percent of Patients With Progression-free Survival at 3 and 6 Months Post Start of Treatment
Progression-free Survival at 6 months
|
50 percent of participants
Interval 18.4 to 75.3
|
20 percent of participants
Interval 3.1 to 47.5
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: The population comprises all subjects who received at least one dose of study treatment.
Overall survival (OS) will be measured for each subject from the date of the first dose of study drug until the recorded date of death or last follow-up. Subjects who are still alive will be censored on the date of last follow-up. Living patients were censored at last off-study follow-up visit, last scan date, or at the end of study if no follow-up was available. OS were estimated by Kaplan-Meier methodology.
Outcome measures
| Measure |
Cohort A (Conventional RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 Participants
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Percent of Patients With Overall Survival at 12 Months Post Start of Treatment
|
56.3 percent of participants
Interval 20.9 to 80.9
|
56.3 percent of participants
Interval 20.9 to 80.9
|
Adverse Events
Cohort A (Conventional RT)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 4 deaths
Cohort B (Hypofractionated RT)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Cohort A (Conventional RT)
n=10 participants at risk
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 participants at risk
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Atrial fibrillation
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Fall
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Mental status changes
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Suprapubic pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Syncope
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
Other adverse events
| Measure |
Cohort A (Conventional RT)
n=10 participants at risk
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a conventional total palliative dose of 30 Gy delivered over 2 weeks in 10 fractions of 3 Gy each.
|
Cohort B (Hypofractionated RT)
n=10 participants at risk
Subjects received concurrent ipilimumab (3 mg/kg IV) and nivolumab (1 mg/kg IV) every 3 weeks for 4 doses (i.e., Weeks 1, 4, 7 and 10), followed by nivolumab monotherapy administered at a dose of 240 mg IV every 2 weeks through Week 18. Continued nivolumab monotherapy was permitted beyond Week 18 at the Investigator's discretion as either 240 mg IV every 2 weeks or 480 mg IV every 4 weeks starting at Week 20. Extracranial RT was initiated after the first dose and before the second dose of immunotherapy and was administered to a target lesion at a hypofractionated high-dose of 27 Gy delivered over 2 weeks in 3 fractions of 9 Gy each.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
5/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dry mouth
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Pancreatitis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal polyp
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Vomiting
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Asthenia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Chills
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Face oedema
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Facial pain
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Fatigue
|
70.0%
7/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
60.0%
6/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Influenza like illness
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Malaise
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Mass
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Oedema peripheral
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Pain
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
General disorders
Pyrexia
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Aspartate aminotransferase increased
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Lipase increased
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Weight decreased
|
60.0%
6/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
50.0%
5/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
50.0%
5/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hot flush
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypertension
|
70.0%
7/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Vascular disorders
Lymphoedema
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.0%
6/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Headache
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
40.0%
4/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Paraesthesia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Tremor
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperactive pharyngeal reflex
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Genital herpes
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Gingivitis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Localised infection
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Mucosal infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Palpitations
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Sinus tachycardia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
30.0%
3/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Uveitis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Vision blurred
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Delirium
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
20.0%
2/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Immune system disorders
Hypersensitivity
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Reproductive system and breast disorders
Pelvic pain
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Surgical and medical procedures
Wound drainage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Eye disorders
Blepharitis
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Blood alkaline phosphatase increased
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Dyskinesia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Laceration
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Proctalgia
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Gastrointestinal disorders
Tooth disorder
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Tooth infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour ulceration
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Investigations
Weight increased
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
10.0%
1/10 • All adverse events (AEs) occurring between the signing of informed consent and the off-study date (i.e., through 100 days after the last dose of study treatment) were documented, regardless of the causal relationship to study drug. AEs that occurred or worsened in severity after the first dose of study treatment were considered treatment emergent (i.e., TEAEs).
AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, preferred terms are counted only once per subject at the maximum reported grade.
|
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: (212) 450-1539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60